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• trial_statuses(array)
  • 1Recruiting
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  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id393
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<p>\n Dafra Pharma and CCR-KEMRI have initiated the first in man clinical Phase 1 study<br />\n using single oral doses of 50 mg, 100 mg and 150 mg of oleylphosphocholine in healthy<br />\n adult males (protocol DRD140-L2.2012, SSC #2512). The study made use of a capsule<br />\n formulation of oleylphophocholine containing 50 mg of active ingredient. The subjects of<br />\n the first three cohorts were receiving one, two or three of those capsules as a single dose.<br />\n Based on the positive results obtained so far, two additional cohorts of 10 volunteers are<br />\n now planned to be dosed with single dose of 200 mg and 250 mg, upon approval by<br />\n KEMRI IRB. The capsule formulation of oleylphosphocholine was of limited shelf life and was only<br />\n meant to be used for early clinical studies. Since the initiation of the Phase 1 trial, the<br />\n pharmaceutical research around the formulation of oleylphosphocholine has progressed<br />\n and the final formulation of the active ingredient intended to be marketed has become<br />\n available. This formulation is in the form of 50 mg oral solid tablets. Our intention is to<br />\n continue the Phase 1 protocol DRD140-L2.2012, SSC #2512 with this new formulation,<br />\n but before, we wish to confirm that both the capsule and tablet formulations of the active<br />\n ingredient are comparable in terms of safety/tolerance, and pharmacokinetics.The primary objective is to evaluate safety and tolerability of single dose 100 mg<br />\n oleylphosphocholine oral solid tablets in healthy male volunteers.The secondary objective is to obtain data on pharmacokinetics following oral<br />\n administration of single dose 100 mg tablets oleylphosphocholine in human, and to<br />\n calculate bioequivalence with the capsule formulation</p>\n<p>\n  </p>\n
      • study_title<p>\n Plasma concentration profiles after oral<br />\n administration of oleylphosphocholine tablet<br />\n formulation: safety, tolerability and pharmacokinetics<br />\n of 100 mg single dose in healthy male volunteers.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/04/02
      • version_no2.1
      • date_of_protocol03-02-2015
      • study_drugOleylphosphocholine (OlPC)
      • disease_conditionleishmaniasis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameOleylphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Rashid J R
      • declaration_date129-04-2015
      • declaration_principal_investigatorDr Njenga S Njoroge CO_PI
      • declaration_date229-04-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Healthy males, adults, aged 18-45 years inclusively at the time of screening.<br />\n · Weight between 45 kg and 80 kg inclusively.<br />\n · Written informed consent obtained from the participant before study start.</p>\n
      • principal_exclusion_criteria<p>\n HIV positive or other immunosuppressive statusSymptomatic infection<br />\n · Concomitant exposure to other investigational medicinal products<br />\n · History of alcohol or drug abuse<br />\n · Known hypersensitivity to miltefosine<br />\n · Known skin condition which could confound assessments of rash as an adverse event.<br />\n · Lipid disorders, including abnormal blood levels of total cholesterol, HDL, LDL, and<br />\n triglycerides.<br />\n · Laboratory result abnormalities, including clinically significant abnormal ECG, liver function<br />\n tests more than x3 upper limit of normal, creatinine outside normal range.<br />\n · Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. Or any<br />\n other findings that in the opinion of the PI may increase the risk to the participant from<br />\n participating in the study.<br />\n · Other condition that in the opinion of the investigator would jeopardize the safety or rights of<br />\n a participant in the trial or would render the participant unable to comply with the protocol.</p>\n
      • primary_end_points<p>\n Documentation of solicited and spontaneously reported adverse events after administration<br />\n during a 29-day follow-up period, i.e. from day 0 (day of administration) to day 28 postadministration.<br />\n · Documentation of the occurrence of serious adverse events (SAE) throughout the study<br />\n period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to<br />\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are<br />\n dedicated to Phase 1 clinical trials.<br />\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre<br />\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The<br />\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for<br />\n maintenance and for running the different tests.<br />\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory<br />\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17<br />\n research nurses. A pharmacy and a qualified pharmacist are also present on site.<br />\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP<br />\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.<br />\n The team of CCR has conducted several clinical trials including Phase 1 studies.</p>\n
      • other_details_explanation<p>\n Dafra Pharma distributes its products exclusively on the African market and has always<br />\n focused on making drugs available for the African population, where the need is high and<br />\n drugs need to be affordable. Therefore it is ethically fair that the African population and<br />\n scientific community, who are likely to use the medicine in clinical practice, participate in<br />\n the clinical development. This will allow reliable and accurate data about tolerance and<br />\n pharmacokinetics to be compiled in the target population.<br />\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a<br />\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic<br />\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to<br />\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic<br />\n profile of OlPC in healthy Kenyan volunteers.<br />\n  </p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n NONE</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_durationEnrolment and clinical part: up to 3 months Data analysis and preliminary report: 2 months Final report: 1 month
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI
      • single_site_physical_addressoff mbagathi way
      • single_site_contact_personDr J R Rashid
      • single_site_telephone254 20 2726781
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide10
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRashid Juma
      • investigator1_middle_name
      • investigator1_family_nameRavasco
      • investigator1_qualificationMedical Doctor MBChB, MMed(medicine)
      • investigator1_professional_addressCenter for Clinical Research Kenya Medical Research Institute (KEMRI) Box 20778-00202 Nairobi, Kenya
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants10
      • notification
      • approval_date15-06-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-06-15 19:23:44
      • created2015-04-29 08:57:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id266
        • application_id393
        • given_nameRavasco
        • middle_nameRashid
        • family_nameJuma
        • qualificationMBChB Mmed(Internal Medicine)
        • professional_address KEMRI 54840-00200 Nairobi
        • telephone0723726526
        • emailjrashid@kemri.org
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
    • SiteDetail(array)
      • 0(array)
        • id322
        • application_id393
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id205
        • application_id393
        • sponsorDafra Pharma International NV
        • sponsor_type(null)
        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 61 78 20
        • fax_number+32 14 47 29 90
        • cell_number+32 475 912 920
        • email_addressbruno.jansen@dafra.be
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
  • 1(array)
    • Application(array)
      • id391
      • user_id271
      • trial_status_id6
      • abstract_of_study<p>\n The goal of this project is to evaluate the acceptability of three multipurpose prevention technology (MPT) delivery forms for prevention of HIV and unintended pregnancy among young women in Kenya and South Africa: a vaginal ring, an injectable, and a co-formulated daily oral tablet (all placebos).</p>\n<p>\n This research will integrate data collected through three primary activities: 1) a clinical study in which HIV-negative, non-pregnant young women will all receive condoms as standard of prevention, and be asked to use each of three placebo product for 1 month, in a randomly allocated order, to determine product preference (cross-over period), and then use their favorite product for up to 2 months; 2) qualitative in-depth interviews (IDIs) with women, their male partners, and health providers (HP); and 3) a structured discrete choice survey with the clinical study participants  and a community-recruited sample of product-naïve young women. Rankings, product relative preference (including male condoms), and use data for MPT placebo delivery formulations and specific delivery form attributes will be identified, with the overall goal of informing further development of MPT to optimize the likelihood of end-user adoption. In addition, data collection activities will be designed to inform development of culturally appropriate MPT communication strategies and educational messages tailored for young women in these sub-Saharan African settings.</p>\n<p>\n This research will help identify how products and their attributes are viewed by young women at dual risk of HIV and unintended pregnancy, and how messaging about the products can be appropriately tailored to increase adoption of novel formulation(s). This will enhance the potential public health impact of MPT to address the two critical women’s health issues.</p>\n
      • study_title<p>\n The TRIO Study: Acceptability of Different Multipurpose Prevention Technology (MPT) Delivery Methods (Placebo)</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/05/02
      • version_no1.0
      • date_of_protocol11-02-2015
      • study_drugPLACEBO FORMULATIONS OF VAGINAL RING, AN INTRAMUSCULAR INJECTION AND AN ORAL PILL.
      • disease_conditionHIV AND PREGNANCY PREVENTION
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_name1. PLACEBO VAGINAL RING: A FLEXIBLE SILICON ELASTOMER 56mm IN DIAMETER AND 7.6mm THICK; PLACEBO ORAL PILL;
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmamagigto@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKAWANGO AGOT
      • declaration_date107-05-2015
      • declaration_principal_investigatorNational Principal Investigator.
      • declaration_date207-05-2015
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Age 18-30</p>\n<p>\n In good health, as determined by the site Investigator or designee based on clinical history</p>\n<p>\n Willing and able to comply with study procedures and attend monthly follow-up visits</p>\n<p>\n Willing and able to provide informed consent</p>\n<p>\n Fluent in one of the languages being used in the study (Setswana and English in South Africa; Luo, Kiswahili, and English in Kenya)</p>\n<p>\n Not intending to travel outside of the research catchment area for the next 6 months.</p>\n<p>\n Sexually active defined by vaginal intercourse with a male at least 3 times in the past 3 months</p>\n
      • principal_exclusion_criteria<p>\n HIV positive</p>\n<p>\n Pregnant</p>\n<p>\n Prior participation in any HIV-prevention or MPT product demonstration study or clinical trial</p>\n<p>\n Any current or historical health or psychological issues that the site Investigator or his/her designee determines should exclude the potential participant</p>\n
      • primary_end_points<p>\n Three Primary Endpoints (outputs): product ratings after each period in the cross-over study; preference, indicated by choice among the three delivery forms at the end of the cross-over period; and use)</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability study.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyAn acceptability study on HIV and Pregnancy prevention through multipurpose prevention technologies.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n APPROXIMATELY 15 20 personnel will be hired to work in the study team at Kenyan site. A few positions have now been filled:</p>\n<p>\n 1 Site Principal Investigator; KAWANGO AGOT, PhD; Dr. Kawango has been a principal Investigator in several HIV prevention studies in the fields of Pre-exposure prophylaxis among women, Behavioral Interventions and Male Circumcision.</p>\n<p>\n 2 Study Coordinator: FREDRICK OWINO, MBChB; Dr. Owino brings on board experience in coordinating clinical studies in the fields of Pre-exposure prophylaxis and Implementation science research.</p>\n<p>\n 3. Study Pharmacist; PAUL MAK'OKETCH, B Pharm; Dr. Makoketch has more that 3 years experience in pharmacy practice in clinical trials. Paul worked as Trial pharmacist in Pre-exposure prophylaxis with antiretrovirals.</p>\n<p>\n NurseCounsellors(2)</p>\n<p>\n Registered Clinical Officer(1)</p>\n<p>\n Pharmaceutical Technologist(1)</p>\n<p>\n Interviewers(1)</p>\n<p>\n Accountant(1)</p>\n<p>\n Data Clerks(4)</p>\n<p>\n STUDY SITE:</p>\n<p>\n The study will be conducted at IRDO’s Tuungane Youth Center Clinic, located within Kisumu City. Tuungane offers clinical services, including HIV care and treatment, HIV testing and counseling, STI screening and management, and voluntary medical male circumcision. In addition, Tuungane has a pharmacy where the study products will be stored and a qualified and registered Pharmaceutical Technologist who will dispense the study products. Tuungane also has a mini laboratory equipped with both -8 and -70 fridges for sample storage, a biosafety cabinet, centrifuges and ample storage space for other study supplies. The space, including examination rooms, is sufficient to comfortably accommodate the study.The study will be conducted at IRDO’s Tuungane Youth Center Clinic, located within Kisumu City. Tuungane offers clinical services, including HIV care and treatment, HIV testing and counseling, STI screening and management, and voluntary medical male circumcision. In addition, Tuungane has a pharmacy where the study products will be stored and a qualified and registered Pharmaceutical Technologist who will dispense the study products. Tuungane also has a mini laboratory equipped with both -8 and -70 fridges for sample storage, a biosafety cabinet, centrifuges and ample storage space for other study supplies. The space, including examination rooms, is sufficient to comfortably accommodate the study.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n This study will focus on MPT preference, choice, and use among young women (aged 18 to 30years) in sub-Saharan Africa as a primary target population due to high risk for both unintended pregnancy and HIV acquisition in this region. For this reason two study sites have been identified in Kenya and South Africa. The United States, the sponsor's host country,  does not face massive challenges of both unintended pregnancies and HIV infection among young women and would not make an ideal study location.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute Ethics Review Committee (KEMRI-ERC)</p>\n
      • other_details_regulatory_rejected<p>\n NOT APPLICABLE</p>\n
      • other_details_regulatory_halted<p>\n NOT APPLICABLE</p>\n
      • estimated_duration18 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaTuungane Youth Center Clinic
      • single_site_physical_addressAlong Mito-Jura Road, Kisumu
      • single_site_contact_personKawango Agot
      • single_site_telephoneTel: 057-2020132 Mobile: 0723511113
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listSouth Africa, Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_siteAPPROXIMATELY 140
      • total_participants_worldwide280
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameARIANE
      • investigator1_middle_name
      • investigator1_family_nameVAN DER STRATEN
      • investigator1_qualificationPhD
      • investigator1_professional_address RTI International, San Francisco Project Office 351 California St, Suite 500 San Francisco, CA 94101-2414
      • investigator1_telephone+1-415-848-1322
      • investigator1_emailariane@rti.org
      • organisations_transferred_Yes
      • number_participantsAPPROXIMATELY 140
      • notification<p>\n We have attached a scanned copy of  bankers cheque of value 1000USD at the 'checklist' section of this online application. The actual cheque has been sent by courier to your offices and addressed to the Secretary of the ECCT.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • approval_date13-10-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-05-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Please find attached documents as part of the executive summary report.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-10-06 12:09:05
      • created2015-04-15 13:00:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id265
        • application_id391
        • given_nameKawango
        • middle_name
        • family_nameAgot
        • qualificationPhD
        • professional_addressBaring Drive, Off Awuor Otiende Road, Opposite KBC Station P. O. Box 9171-40141 Kisumu, Kenya
        • telephoneTel: 057-2020132
        • emailmamagifto@yahoo.com
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
    • SiteDetail(array)
      • 0(array)
        • id321
        • application_id391
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id204
        • application_id391
        • sponsorRTI International
        • sponsor_type(null)
        • contact_personRachel Weinrib
        • addressRTI International, San Francisco Project Office. 351 California St, Suite 500. San Francisco, CA 94101-2414
        • telephone_number+1-415-848-1322
        • fax_number
        • cell_number+1-415-848-1322
        • email_addressrweinrib@rti.org
        • created2015-04-15 13:07:00
        • modified2015-05-19 12:12:03
  • 2(array)
    • Application(array)
      • id389
      • user_id263
      • trial_status_id5
      • abstract_of_study<p>\n The trial is being conducted as an effectiveness trial with the objective of the experimental intervention being registered for the indication “prevention of postpartum haemorrhage” by drug regulatory authorities if it is shown to be non-inferior or superior to the gold standard control, oxytocin. For this purpose a primary endpoint of blood loss 500 mL or more or use of additional uterotonics is considered appropriate. For the purpose of evaluating clinical effectiveness and for inclusion of the experimental intervention in future WHO guidelines and the Model List of Essential Medicines, the more substantive endpoint of blood loss 1000 mL or more is considered appropriate. The blood loss of 1000 mL or more was considered as one of the three critical endpoints (together with blood transfusion and maternal death) for the earlier 2007 WHO recommendations for PPH prevention where outcomes were rated by an independent panel. Since the two primary endpoints serve independent objectives, the Type I error rate for multiplicity of endpoints was not adjusted. </p>\n<p>\n <u><strong>The trial has two primary objectives:</strong></u></p>\n<p>\n (1) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n (2) To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n <u><strong>For both objectives the hypotheses are:</strong></u></p>\n<p>\n i) Carbetocin RTS 100 μg/ml IM is non-inferior to oxytocin 10IU IM in terms of the proportion of women with blood loss ≥500 mL or use of additional uterotonic drugs after vaginal delivery within a non-inferiority margin of 1.16 on the relative risk scale (objective (1)), and the proportion of women with blood loss ≥1000 mL after vaginal delivery within a non-inferiority margin of 1.23 on the relative risk scale (objective (2)).</p>\n<p>\n <em>Justification</em>: In the conventional superiority trial, the aim is to determine whether one intervention is superior to another, for example, whether an uterotonic is superior to nothing. By contrast, in a non-inferiority trial, the aim is to determine whether an alternative intervention with certain advantages is similar to a gold standard. Oxytocin 10 IU (IM or IV) represents the gold standard management strategy for reducing blood loss in the third stage of labour. The advantages of carbetocin RTS are being more heat-stable than oxytocin and having a longer half-life. In order to evaluate the effectiveness of carbetocin RTS, which has these advantages, it has to be compared to oxytocin to assess whether it is non-inferior to it in efficacy.</p>\n<p>\n ii) Carbetocin RTS 100 μg IM is superior to oxytocin 10 IU IM in terms of the proportion of women with blood loss ≥500 mL or use of additional uterotonic drugs (objective (1)), and in terms of the proportion of women with blood loss ≥1000 mL after vaginal delivery (objective (2)). For each of the two primary endpoints, superiority will be tested if non-inferiority has been demonstrated.</p>\n<div>\n  </div>\n<div>\n <u>Rationale</u>: Superiority of the new treatment for the primary outcome would be an additional</div>\n<div>\n benefit. If carbetocin is demonstrated to be superior to oxytocin in efficacy, it would be the</div>\n<div>\n preferred option.</div>\n
      • study_title<p>\n A phase III, randomized, double-blind, active, controlled, multinational, multicentre,  non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally.</p>\n
      • laymans_summary<p>\n PPH is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. PPH is a significant contributor to severe maternal morbidity and long term disability, as well as to a number of other severe maternal conditions, generally associated with more substantial blood loss, including shock and organ dysfunction2-4. Improving health care for women during childbirth in order to prevent and treat PPH is an essential step towards the achievement of the United Nations Millennium Development Goals.</p>\n<p>\n Despite oxytocin being a well-known and extensively studied, there is limited information on its stability at tropical temperatures, mainly at extreme climate conditions and storage under refrigeration is recommended, however carbetocin RTS is a promising intervention for reducing PPH particularly in settings where cold storage is difficult to achieve and maintain.</p>\n<p>\n Merck for Mothers is a 10-year initiative focused on creating a world where no woman has to die from complications of pregnancy and childbirth. Two of its priority areas are postpartum haemorrhage (PPH) and hypertensive disorders of pregnancy.</p>\n<p>\n carbetocin RTS is a promising intervention for reducing PPH particularly in settings where cold storage is difficult to achieve and maintain. An international technical consultation was convened and it was agreed to proceed with a randomized controlled trial to evaluate the effectiveness of carbetocin RTS compared to oxytocin when used intramuscularly. This was based on four considerations:</p>\n<p>\n (i) frequent concerns and documentation of the quality of oxytocin and its stability in some developing countries;</p>\n<p>\n (ii) the potential advantage of carbetocin RTS due to its longer half-life (than oxytocin) especially when administered intramuscularly in addition to its heat stability;</p>\n<p>\n (iii) research will be funded by Merck for Mothers and conducted by WHO independently in terms of the management, analysis and publication of the research results</p>\n<p>\n (iv) if non-inferior to oxytocin, carbetocin RTS formulation will be made available in high-burden countries at an accessible public sector price comparable to the current oxytocin price based on a signed memorandum of understanding between WHO, Ferring and Merck.</p>\n<p>\n  </p>\n
      • short_titleA phase III, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering
      • protocol_noECCT/15/03/01
      • version_noVersion 1.1
      • date_of_protocol08-12-2014
      • study_drugCarbetocin RTS 100 μg and oxytocin 10 IU.
      • disease_conditionPostpartum haemorrhage
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameWomen will receive a single intramuscular dose of either oxytocin or carbetocin immediately after the birth of the baby
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameOxytocin
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbianca.hibbert@quintiles.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantBianca Hibbert
      • declaration_date105-03-2015
      • declaration_principal_investigatorProfessor Zahida Qureshi
      • declaration_date205-03-2015
      • placebo_presentNo
      • study_objectives<ul>\n <li>\n <strong>To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</strong></li>\n <li>\n <strong>To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour</strong></li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n <strong>To be eligible for inclusion into this trial, the women must fulfill all the following criteria:</strong></div>\n<div>\n  </div>\n<div>\n 1. Be expected to deliver vaginally</div>\n<div>\n 2. Have a cervical dilatation equal to or less than 6cm</div>\n<div>\n 3. Have a known singleton pregnancy</div>\n<div>\n 4. Provide written informed consent before any trial-related procedures are carried out.</div>\n
      • principal_exclusion_criteria<div>\n <strong>Women are not eligible for this trial if they fulfill any of the following exclusion criteria:</strong></div>\n<div>\n  </div>\n<div>\n 1. Are in an advanced first stage of labour (>6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation</div>\n<div>\n 2. Are non-emancipated minors (as per local regulations) without a guardian</div>\n<div>\n 3. Have been scheduled for a planned caesarean section</div>\n<div>\n 4. The birth is considered an abortion according to local guidelines</div>\n<div>\n 5. Have known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial</div>\n<div>\n 6. Have serious cardiovascular disorders</div>\n<div>\n 7. Are not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder</div>\n
      • primary_end_points<p>\n (1) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n (2) To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The Kenyatta National Hospital labour ward has 40 full time nurse/midwives. The Hospital it a Tertiary referral site where approximately 13,000 deliveries are conducted and the Caesarean sections rate is around 35%. There is 24 hour theatre coverage , one theatre is for emergencies is functional 24 hours and the second one for elective surgeries is operational Monday to Friday 8am to 5pm. Both theatres are in labour ward. The hospital has a High dependency unit and an ICU.</p>\n<p>\n There is full time consultant coverage with the postgraduates being first on call.</p>\n<p>\n The study will employ one Project coordinator who will be a midwife and will oversee the running of the project and supervise the six midwives (research midwives )we will employ to work in labour ward on shift duty to carry out the recruitment for patients and  delivery as per study protocol and data collection.</p>\n<p>\n In addition a Data entry clerk will be employed for data entry. Prof. Zahida P Qureshi will be overall incharge and Dr Osoti will assist.</p>\n
      • other_details_explanation<p>\n This study is being conducted in developing countries where the PPH incidence and the need for a heat stable treatment for PPH are high. The only exceptions are UK and Singapore which were included for registration purposes.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:210px;\">\n <p>\n <strong>Countries </strong></p>\n </td>\n <td style=\"width:409px;\">\n <p>\n <strong> Competent Authority  Name and Address </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n South Africa</td>\n <td style=\"width:210px;\">\n <p>\n The Registrar    </p>\n Medicines Control Council<br />\n Hallmark Building<br />\n PRETORIA<br />\n 0001</td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n UK</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Information Processing Unit<br />\n Area 6<br />\n MHRA<br />\n 151 Buckingham Palace Road<br />\n Victoria<br />\n SW1W 9SZ</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Uganda National Council For Science And Technology (UNCST) Research</p>\n <p>\n Uganda National Council for Science & Technology, Plot 6 Kimera Road Ntida, Kampala</p>\n <p>\n Uganda</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n National Agency for Food and Drug Administration and Control (NAFDAC)</p>\n <p>\n Plot 2032, Olusegun Obasanjo Way, Wuse Zone 7-Abuja FCT Nigeria.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Egypt</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Ministry of Health - Central Directorate for Research & Health Development (The new administrative building – floor 7)</p>\n <p>\n 3 Magles El Shaab St.</p>\n <p>\n Cairo.</p>\n <p>\n P.O.: 11516</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n India</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Drugs Controller General (India),</p>\n <p>\n Directorate General of Health Services</p>\n <p>\n FDA Bhavan</p>\n <p>\n Kotla Road</p>\n <p>\n New Delhi</p>\n <p>\n 110002</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Singapore</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Health Sciences Authority</p>\n <p>\n 11 Outram Road<br />\n Singapore</p>\n <p>\n 169078</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Thailand</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Food and Drug Administration Ministry of Public Health</p>\n <p>\n Thiwanon Road</p>\n <p>\n Nonthaburi</p>\n <p>\n 11000</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Argentina</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n MOH –ANMAT</p>\n <p>\n Avenida de Mayo 869 (C1084AAD)</p>\n <p>\n Ciudad Autónoma de Buenos Aires</p>\n <p>\n Argentina</p>\n <p>\n  </p>\n <p>\n And</p>\n <p>\n  </p>\n <p>\n Regional MOH.- Santa Fe province</p>\n <p>\n Bv. Pellegrini 3100, 1er. P – Santa Fe  (3000) Santa Fe Argentina</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;height:61px;\">\n <p>\n Brazil</p>\n </td>\n <td style=\"width:409px;height:61px;\">\n <h5>\n ANVISA – Agência Nacional de Vigilância Sanitária</h5>\n <p>\n COPEC - Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos</p>\n <p>\n Setor de Indústria e Abastecimento (SIA)</p>\n <p>\n Trecho 5, Área Especial 57, 71205-050 – Brasília – DF – Brazil</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n Applications for only South Africa, UK, Nigeria and Egypt have been submitted. And no approvals. There were submissions prior to the Quintiles involvement, e.g. in India, and some other countries, but with the previous protocol, without ICFs etc. Some EC approvals were received, but need to be amended with the current submission to be valid.</p>\n
      • other_details_regulatory_rejected<p>\n No approvals or rejections received as yet.</p>\n
      • other_details_regulatory_halted<h3 style=\"color:blue;\">\n <span dir=\"rtl\"><span style=\"color:#000000;\"><tt><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not applicable</span></span></tt></span></span></h3>\n
      • estimated_durationThe total study duration will be approximately 24 months.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifymultinational, multicentre, noninferiority trial
      • design_controlled_comparatorCarbetocin RTS
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyoxytocin
      • single_site_member_stateYes
      • location_of_areaKenyatta National Hospital
      • single_site_physical_addressKenyatta National Hospital, Nairobi, Kenya
      • single_site_contact_personProf. Zahida P Qureshi
      • single_site_telephoneDepartment 2726300 Ext. 43372 or 2726360
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states11
      • number_of_sites
      • multi_country_listArgentina, Brazil, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.
      • data_monitoring_committeeYes
      • total_enrolment_per_site4000 participants
      • total_participants_worldwideApproximately 30\'000 women delivering vaginally will be recruited in this trial.
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_name Qureshi
      • investigator1_qualificationMasters of Medicine in Obstetrics and Gynecology, Bachelor of Medicine and Bachelor of Surgery
      • investigator1_professional_addressKenyatta National Hospital
      • investigator1_telephoneDepartment 2726300 Ext. 43372 or 2726360 or 0733 605140
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participantsIn Kenya, approximately 4000 participants will be taking part in the study.
      • notification<p>\n WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.</p>\n
      • approval_date27-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The result of this trial indicate that carbetocin and oxytocin have similar efficacy profiles in the prevention of PPH.  The co-primary objective for blood loss of 500mL or more or use of additional uterotonics was met with carbetocin demontrating non-inferiority compared with oxytocin. However, the co primary objective for blood loss of 1000mL with carbetocion demonstrating non-inferiority compared with oxytocin was not met. Although the upper limit of 95% CI for co-primary outcome blood loss of 1000mL or more was just above the margin of non-inferiority, most likely values for RR were below the margin, suggesting that the trial was slightly underpowered to show non-inferiority for this outcome.  The overall AE data are consistant with the established safety profiles and show minimal differences between carbetocin and oxytocin.  BAsed on the overall efficacy and safety profiles, carbetocin and oxytocin appear to offer cimilar treatment outcomes</p>\n<p>\n The date of global end of trial was 07 March 2018. The Global end of trial is defined as the date the final clinical database lock.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-26 12:23:55
      • created2015-02-16 10:14:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id264
        • application_id389
        • given_nameZahida
        • middle_name
        • family_name Qureshi
        • qualificationMasters of Medicine in Obstetrics and Gynecology, Bachelor of Medicine and Bachelor of Surgery
        • professional_addressKenyatta National Hospital
        • telephoneDepartment 2726300 Ext. 43372 or 2726360 or 0733 605140
        • emailzahida@qureshi.co.ke
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
    • SiteDetail(array)
      • 0(array)
        • id316
        • application_id389
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id203
        • application_id389
        • sponsorWorld Health Organization
        • sponsor_typeOthers
        • contact_personDr A. Metin Gülmezoglu
        • addressDepartment of Reproductive Health & Research, Avenue Appia 20, 1211 Geneva 27, Switzerland
        • telephone_number+41-22-7913417
        • fax_number+41-22-7914171
        • cell_number+41-22-7913417
        • email_addressgulmezoglum@who.int
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
  • 3(array)
    • Application(array)
      • id387
      • user_id32
      • trial_status_id5
      • abstract_of_study<div>\n  </div>\n<div>\n Short Title: IVERMAL study</div>\n<div>\n  </div>\n<div>\n Background and rationale: In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40% in 2008, where it has now stagnated. Innovative approaches are needed to continue towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal effects. Regulatory studies have shown ivermectin is very well tolerated and safe even up to 2,000 mcg/kg. We will conduct dose finding studies to evaluate the transmission blocking effect of high-dose ivermectin to define the optimal dose for future use of ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug administration (MDA) for malaria in Kenya. This study explores a research question of global relevance. A prolonged transmission blocking effect of ivermectin could have substantial consequences for malaria control in the next decades. We expect the results to inform the national regulator in Kenya, national malaria control programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the regulatory process.</div>\n<div>\n  </div>\n<div>\n Primary objective: To determine the safety and efficacy of ivermectin 0, 300, 600 mcg/kg/day for 3 days, when provided with a standard 3-day course of dihydroartemisinin-piperaquine (DP) for uncomplicated malaria, on 14-day mosquito survival after feeding experiment performed at 7 days after treatment.</div>\n<div>\n Hypothesis: High dose ivermectin at 600 mcg/kg daily for 3 days is well tolerated and safe and will have a longer lasting mosquitocidal effect and a greater potential impact on malaria transmission.</div>\n<div>\n  </div>\n<div>\n Overview Study Design: Double-blind placebo-controlled, parallel-group, 3-arm, superiority trial to determine the effect of different doses of ivermectin on mosquito survival. The unit of randomization will be the patient, and the unit of analysis will be the mosquito. The primary endpoint will be mosquito survival 14 days after a feed on blood from a patient who has started ivermectin 7 days earlier (i.e. about 5 days after the last dose of ivermectin with a 3-day regimen administering ivermectin at 0, 24, and 48 hours [days 0, 1 and 2]). Because mosquito feeding involves approximately 100 mosquitoes per feed, the study will use a cluster randomized design with the patient as the cluster unit. The study will have a nested rich pharmacokinetic component in the first 12 patients per study arm, and a sparse sampling population pharmacokinetic component in the remaining patients. The study will also compare the potential modifying effect of the method of feeding by comparing the mosquitocidal effect of ivermectin with membrane versus direct skin feeding.</div>\n<div>\n Sites: The study will be conducted in the Provincial Hospital in Kisumu, western Kenya recently renamed to the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Dependent on the recruitment rate, enrolment will be expanded to up to 3 other hospitals in Kisumu and Siaya counties.</div>\n<div>\n Study Population: Adults with uncomplicated falciparum malaria attending out-patient clinics.</div>\n<div>\n  </div>\n<div>\n Study Interventions: 1. Dihydroartemisinin-piperaquine (DP) alone, DP plus ivermectin 0 mcg/kg/day for 3 days (“placebo” arm); 2. DP plus ivermectin 300 mcg/kg/day plus 300 mcg/kg/day ivermectin-placebo for 3 days (“300 mcg/kg” arm); 3. DP plus ivermectin 600 mcg/kg/day (“600 mcg/kg” arm).</div>\n<div>\n Outcome Measures: Primary efficacy outcome: Mosquito survival: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier. Primary safety outcome measure: Mydriasis quantitated by pupillometry. Key secondary safety outcome: QTc(F) prolongation by ECG.</div>\n<div>\n  </div>\n<div>\n Follow-up procedures: Treatment visits on day 1 and 2. Post-treatment follow-up at day 2 (+4 hours after last dose of ivermectin), days 7, 10, 14, 21, and 28.</div>\n<div>\n Sample size: Main trial: 141 participants (47 per arm); Rich pharmacokinetic study: 36 participants (12 per arm); direct feeding vs membrane feeding 27 participants (9 per arm, day 7 post ivermectin only).</div>\n<div>\n  </div>\n<div>\n Data Analysis: Primary outcomes will be summarised by number (%) of events and analysed using a Generalized Estimating Equations (GEE) model with binomial distribution and log link function that includes treatment as a single predictor taking the cluster design into account, which will generate risk ratios together with their 95% confidence intervals of having a primary endpoint between two active dose groups and the placebo group. Exchangeable covariance structure will be used. The primary endpoint analysis will be based on the ITT population.</div>\n<div>\n  </div>\n<div>\n Partner institutions: KEMRI and CDC Collaboration, Kisumu, western Kenya; Kenya Ministry of Health, Liverpool School of Tropical Medicine; US Centers for Disease Control and Prevention</div>\n<div>\n  </div>\n<div>\n Funding: Malaria Eradication Scientific Alliance (MESA) which is funded through a grant from the Bill and Melinda Gates Foundation.</div>\n
      • study_title<p>\n <font face=\"Arial, sans-serif\"><span style=\"line-height: 18.3999996185303px;\"><b>Efficacy and safety of high-dose Ivermectin for reducing malaria transmission: A dose finding study</b></span></font></p>\n
      • laymans_summary<p>\n --</p>\n
      • short_titleIVERMAL study
      • protocol_noECCT/15/02/03
      • version_no1.4
      • date_of_protocol27-01-2015
      • study_drugIvermectin
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameIvermectin
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstsang@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement0
      • declaration_applicantTony Sang
      • declaration_date116-02-2015
      • declaration_principal_investigatorMenno Smit
      • declaration_date216-02-2015
      • placebo_presentYes
      • study_objectives<div>\n The overall aim of the study is to compare the effect of 3-day courses with ivermectin 0, 300, 600 mcg/kg/day when given in combination with standard 3-day course of dihydroartemisinin-piperaquine, on mosquito survival.</div>\n<div>\n  </div>\n<div>\n PRIMARY OBJECTIVE</div>\n<div>\n  </div>\n<div>\n To determine the safety and efficacy of ivermectin 0, 300, 600 mcg/kg/day for 3 days, when provided with a standard 3-day course of dihydroartemisinin-piperaquine (DP) for uncomplicated malaria, on 14-day mosquito survival after feeding experiment performed at 7 days after treatment (i.e. 5 days after the last dose of ivermectin).</div>\n<div>\n  </div>\n<div>\n SECONDARY OBJECTIVES</div>\n<div>\n  </div>\n<div>\n 1. To determine the effect of different doses of ivermectin on oocyst and sporozoite rates.</div>\n<div>\n 2. To determine the effect of different doses of ivermectin on other ectoparasites (e.g. head lice, scabies).</div>\n<div>\n 3. To determine the pharmacokinetic profile of the different ivermectin regimens</div>\n<div>\n 4. To determine if ivermectin interacts with the pharmacokinetics of piperaquine</div>\n<div>\n 5. To determine whether the addition of ivermectin to DP interacts with the ability of DP to clear asexual and sexual stage parasites</div>\n<div>\n 6. To determine the role of genetic variants of CYP3A4 activity in metabolizing ivermectin</div>\n<div>\n 7. To determine the effect of direct feeding versus membrane feeding on mosquito surviv</div>\n
      • principal_inclusion_criteria<div>\n •<span class=\"Apple-tab-span\" style=\"white-space: pre;\"> </span>Asymptomatic, uncomplicated Plasmodium falciparum infection</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Positive malaria microscopy or malaria RDT (pLDH)</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Age: 18-50 years</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Provide written informed consent</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28</div>\n<div>\n  </div>\n<div>\n  </div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n  </div>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Signs or symptoms of severe malaria</p>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Unable to provide written informed consent</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>For women: pregnancy or lactation</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Hypersensitivity to ivermectin or DP</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Qtc > 460 ms on ECG</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Body Mass Index (BMI) below 16 or above 32 kg/m2</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Haemoglobin concentration below 9 g/dL</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Taken ivermectin in the last month</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Taken dihydroartemisinin-piperaquine in the last 12 weeks</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>History and/or symptoms indicating chronic illness</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Current use of tuberculosis or anti-retroviral medication</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Previously enrolled in the same study</div>\n<div>\n  </div>\n
      • primary_end_points<ul>\n <li>\n Mosquito survival: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Study Coordinator, Menno Smit</div>\n<div>\n Project manager, Elizabeth Nyothach</div>\n<div>\n Pharmacist, Tony Sang</div>\n<div>\n Regulatory Officer, Juliana Kisakye</div>\n<div>\n Clinical Officer 1, name TBC</div>\n<div>\n Clinical Officer 2, name TBC</div>\n<div>\n Clinical Officer 3, name TBC</div>\n<div>\n Microscopist 1, name TBC</div>\n<div>\n Microscopist 2, name TBC</div>\n<div>\n Phlebotomist 1, name TBC</div>\n<div>\n Laboratory technician 1, TBC</div>\n<div>\n Entomology laboratory assistant 1, TBC</div>\n<div>\n Entomology laboratory assistant 2, TBC</div>\n<div>\n Data manager, TBC</div>\n<div>\n Data clerk, TBC</div>\n<div>\n  </div>\n<div>\n The study will be conducted in the Provincial Hospital in Kisumu, western Kenya recently renamed to the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). JOOTRH is a major tertiary care hospital with self-contained paediatric, medical, and obstetric wards, as well as an intensive care unit with mechanical ventilators and telemetry capabilities. Almost 25,000 outpatients are treated for clinical malaria at JOOTRH annually, of which one-third are laboratory confirmed. Approximately 20% of these patients are 18-50 years old. On a daily basis around 4.6 adults (18–50 years old) test positive for malaria in JOOTRH’s outpatient clinic.</div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n The study involves patients with malaria.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<div style=\"margin-left: 40px;\">\n KEMRI  SSC- 12 Feb 2015</div>\n<div style=\"margin-left: 40px;\">\n  </div>\n<div style=\"margin-left: 40px;\">\n Liverpool School of Tropical Medicine  -   23-Jan-2015</div>\n<div>\n  </div>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration4-6 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sitesOne main site and three potential expansion sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteJaramogi Oginga Odinga Teaching & Referral Hospital : 0-141\nKisumu District Hospital : 0-141\nSiaya District Hospital : 0-141\nV District Hospital: 0-141
      • total_participants_worldwide141
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameMenno
      • investigator1_middle_nameRoderick
      • investigator1_family_nameSmit
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
      • investigator1_telephone+254 703 991513
      • investigator1_emailmenno.smit@liverpool.ac.uk
      • organisations_transferred_Yes
      • number_participants141
      • notification
      • approval_date26-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-01-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has now been approved
      • final_report<div>\n <strong>Summary</strong></div>\n<div>\n Background Ivermectin is being considered for mass drug administration for malaria due to its ability to kill mosquitoes feeding on recently treated individuals. However, standard, single doses of 150–200 μg/kg used for onchocerciasis and lymphatic filariasis have a short-lived mosquitocidal effect (<7 days). Because ivermectin is well tolerated up to 2000 μg/kg, we aimed to establish the safety, tolerability, and mosquitocidal efficacy of 3 day courses of high-dose ivermectin, co-administered with a standard malaria treatment.</div>\n<div>\n  </div>\n<div>\n <strong>Methods</strong> We did a randomised, double-blind, placebo-controlled, superiority trial at the Jaramogi Oginga Odinga Teaching and Referral Hospital (Kisumu, Kenya). Adults (aged 18–50 years) were eligible if they had confirmed symptomatic uncomplicated Plasmodium falciparum malaria and agreed to the follow-up schedule. Participants were randomly assigned (1:1:1) using sealed envelopes, stratified by sex and body-mass index (men: <21 vs ≥21 kg/m²; women: <23 vs ≥23 kg/m²), with permuted blocks of three, to receive 3 days of ivermectin 300 μg/kg per day, ivermectin 600 μg/kg per day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. Blood of patients taken on post-treatment days 0, 2 + 4 h, 7, 10, 14, 21, and 28 was fed to laboratory-reared Anopheles gambiae sensu stricto mosquitoes, and mosquito survival was assessed daily for 28 days after feeding. The primary outcome was 14-day cumulative mortality of mosquitoes fed 7 days after ivermectin treatment (from participants who received at least one dose of study medication). The study is registered with ClinicalTrials.gov, number NCT02511353.</div>\n<div>\n  </div>\n<div>\n <strong>Findings</strong> Between July 20, 2015, and May 7, 2016, 741 adults with malaria were assessed for eligibility, of whom 141 were randomly assigned to receive ivermectin 600 μg/kg per day (n=47), ivermectin 300 μg/kg per day (n=48), or placebo (n=46). 128 patients (91%) attended the primary outcome visit 7 days post treatment. Compared with placebo, ivermectin was associated with higher 14 day post-feeding mosquito mortality when fed on blood taken 7 days post treatment (ivermectin 600 μg/kg per day risk ratio [RR] 2·26, 95% CI 1·93–2·65, p<0·0001; hazard ratio [HR] 6·32,</div>\n<div>\n 4·61–8·67, p<0·0001; ivermectin 300 μg/kg per day RR 2·18, 1·86–2·57, p<0·0001; HR 4·21, 3·06–5·79, p<0·0001). Mosquito mortality remained significantly increased 28 days post treatment (ivermectin 600 μg/kg per day RR 1·23, 1·01–1·50, p=0·0374; and ivermectin 300 μg/kg per day 1·21, 1·01–1·44, p=0·0337). Five (11%) of 45 patients receiving ivermectin 600 μg/kg per day, two (4%) of 48 patients receiving ivermectin 300 μg/kg per day, and none of 46 patients receiving placebo had one or more treatment-related adverse events.</div>\n<div>\n  </div>\n<div>\n <strong>Interpretation </strong>Ivermectin at both doses assessed was well tolerated and reduced mosquito survival for at least 28 days</div>\n<div>\n after treatment. Ivermectin 300 μg/kg per day for 3 days provided a good balance between efficacy and tolerability, and</div>\n<div>\n this drug shows promise as a potential new tool for malaria elimination.</div>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-01-26 12:43:18
      • created2015-02-13 17:23:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id261
        • application_id387
        • given_nameMenno
        • middle_nameRoderick
        • family_nameSmit
        • qualificationMD, MPH
        • professional_addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
        • telephone+254 703 991513
        • emailmenno.smit@liverpool.ac.uk
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
    • SiteDetail(array)
      • 0(array)
        • id314
        • application_id387
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
        • physical_addressKakamega Road, Kisumu, Kenya
        • contact_detailsKEMRI/CDC-CRC, P.O. Box 1578, Kisumu 40100, Kenya
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id318
        • application_id387
        • county_id42
        • site_nameKisumu District Hospital (KDH),
        • physical_addressKisumu
        • contact_detailsP. O. Box 4685, Kisumu
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id319
        • application_id387
        • county_id41
        • site_nameSiaya District Hospital
        • physical_addressSiaya
        • contact_detailsP. O. Box 144, Siaya
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 3(array)
        • id320
        • application_id387
        • county_id38
        • site_nameVihiga District Hospital
        • physical_addressVihiga
        • contact_detailsP.O. Box 1069, Vihiga
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id201
        • application_id387
        • sponsorLiverpool School of Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_personMenno Smit
        • addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
        • telephone_number+254 703 991513
        • fax_number
        • cell_number+254 703 991513
        • email_addressmenno.smit@liverpool.ac.uk
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
  • 4(array)
    • Application(array)
      • id379
      • user_id72
      • trial_status_id5
      • abstract_of_study<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:599px;\" width=\"599\">\n <tbody>\n <tr>\n <td style=\"width:20%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Design:</strong></span></p>\n </td>\n <td style=\"width:80%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">This study, which shall be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use.</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase I will explore use of the no-flip technique with historical data from standard Shang Ring circumcisions in Africa used as the comparison group. Men will be randomized to Shang Ring removal at 7 days vs. being followed to observe for spontaneous detachment,</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase II will be a randomized trial comparing use of topical vs. injectable anesthesia.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Population:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">The study population will include Kenyan men and boys ages 10 years and older seeking circumcision at a study sits. A total of 230 participants will be recruited into Phase I and 345 into Phase II. Because of the possibility that boys and men could have different outcomes, we will recruit participants equally in two age groups in both phases; 10-15 and >15 years old.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Duration:</strong></span></p>\n </td>\n <td style=\"width:450px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Approximately 8 months for completion through follow-up of the two phases of the study (exact timing will depend on recruitment rate). In the first phase, participants shall be followed-up at 7, 14, 21, 28, 35, and 42 days post circumcision, although study participation will end once complete wound healing has been documented. In the second phase, participants shall be followed up at 7 and 42 days post-circumcision. In both phases men will be followed beyond 42 days if necessary to document complete wound healing.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Primary Objectives & </strong></span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Endpoints:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase I: Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique. </span></p>\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase II: Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Sites:</strong></span></p>\n </td>\n <td style=\"width:450px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Homa Bay County Hospital, Homa Bay County, Kenya</span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Vipingo Health Center, Kilifi County, Kenya</span></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<h2>\n <span style=\"font-size:12px;\"><span style=\"font-family:verdana,geneva,sans-serif;\">Simplifying the Shang Ring Technique for Circumcision of Men and Boys</span></span></h2>\n
      • laymans_summary(null)
      • short_titleSimplifying ShangRing Circumcision for Men and Boys
      • protocol_noECCT/15/01/03
      • version_no4
      • date_of_protocol09-01-2015
      • study_drugN/A
      • disease_conditionN/A
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameShang Ring Device
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressqawori@engenderhealth.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantQuentin Awori
      • declaration_date127-01-2015
      • declaration_principal_investigatorMark Barone - Principal investigator
      • declaration_date227-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Aged 10 years and older;</li>\n <li>\n Uncircumcised upon clinical examination;</li>\n <li>\n In good general health;</li>\n <li>\n Free of genital ulcerations or other visible signs of STI upon clinical examination;</li>\n <li>\n Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;</li>\n <li>\n Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater</li>\n <li>\n Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;</li>\n <li>\n Assent from participant less than 18 years old who understand study procedure;</li>\n <li>\n Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);</li>\n <li>\n Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Has a known allergy or sensitivity to lidocaine or other local anesthesia;</li>\n <li>\n Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;</li>\n <li>\n Has known bleeding/clotting disorder (e.g. hemophilia);</li>\n <li>\n Has any congenital genitourinary abnormality;</li>\n <li>\n Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,</li>\n <li>\n Is currently participating in another biomedical research study. </li>\n</ol>\n
      • primary_end_points<p>\n <u><strong>Phase I of study</strong></u></p>\n<p>\n Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique.  </p>\n<p>\n <strong><u>Phase II of study</u></strong></p>\n<p>\n Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyMedical device in individuals above 10 years of age
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Homa Bay</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital surgeon (Homa bayu)\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dr Raymond Simba (Co investigator)- MMED Surg</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Jairus Oketch</li>\n <li>\n (Still to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dan Ouma </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Nereah Obura</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Homa bay distirct hospital - VMMC Theatre</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n ================================================</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Vipingo</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital Clinical Officer in charge\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Judy Kinya (Local PI)</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n (to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Millie Oundo </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n David Mwamkita</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Vipingo Health Center - theatre</p>\n
      • other_details_explanation<p>\n Kenya was the first country where research on the Shang ring as a device for VMMC was conducted (2009). Since then alot of advancement into the use of the device has be gained plus inroads with the ministry of health (VMMC) and various stake holders.</p>\n<p>\n As this study is aimed at further improving the use of the device, Kenya is most suited to provide this environment of advanced research of this kind.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Weil Cornell Medical College - 3 Oct 2014</p>\n<p>\n Kenya Medical Research Institute (KEMRI) - 9th Jan 2015</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRemoval of day 7 group (P
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteNo preset maximum or minimum numbers per site.
      • total_participants_worldwide575
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuentin
      • investigator1_middle_name
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB
      • investigator1_professional_addressABC Place, 2nd floor Waiyaki Way, Westlands, Nairobi
      • investigator1_telephone+254 722 912 616
      • investigator1_emailQAwori@engenderhealth.org
      • organisations_transferred_Yes
      • number_participantsPhase I - 230\nPhase II - 345
      • notification
      • approval_date15-04-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study is now approved
      • final_report<p>\n <strong>Phase 1: Simplifying the ShangRing Technique for Circumcision in Boys and Men: Use of the No-Flip Technique with Randomization to Removal at 7 Days vs. Spontaneous Detachment</strong></p>\n<p>\n Background</p>\n<p>\n Voluntary medical male circumcision is being rolled out to reduce HIV transmission in Sub-Saharan Africa. We assessed safety of the new no-flip ShangRing circumcision technique in males 10 years and older, and determined the clinical course and safety of spontaneous device detachment.</p>\n<p>\n Setting</p>\n<p>\n Two health facilities in Kenya.</p>\n<p>\n Methods</p>\n<p>\n We conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days post-circumcision vs. spontaneous device detachment. The primary outcome was safety of the no-flip technique based on moderate and severe adverse events (AEs). A main secondary outcome was clinical course and safety of spontaneous detachment.</p>\n<p>\n Results</p>\n<p>\n 230 men and boys were circumcised; 114 randomized to 7 day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. There were 6 (5.3%) AEs in the 7-day group and 2 (1.7%) in the spontaneous group; with no significant differences when either were compared to historical data from Africa (p=.07 and p=.79, respectively). There was  no difference in AE rates (p=.169), visit day declared healed (p=.324) or satisfaction (p=.371) between randomization groups. 84 (72.4%) participants in the spontaneous group wore the ShangRing until it detached. The median days to detachment was 14.0 (IQR: 7-21, min-max: 5-35).</p>\n<p>\n Conclusions</p>\n<p>\n The no-flip technique and spontaneous detachment are safe, effective, and acceptable to males 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision. A single device usable across ages would simplify services, supply chain management, training, and educational materials, and facilitate circumcision scale-up.</p>\n<p>\n <strong>Phase 2: Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial</strong></p>\n<div>\n Background</div>\n<div>\n The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use</div>\n<div>\n in men and boys 13 years and above. It has been shown to be faster than conventional</div>\n<div>\n circumcision with comparable adverse event (AE) rates and high client satisfaction.</div>\n<div>\n The fear of pain during circumcision is an important barrier to uptake of voluntary</div>\n<div>\n medical male circumcision (VMMC). Use of topical anesthesia thus presents an</div>\n<div>\n opportunity to address this.</div>\n<div>\n  </div>\n<div>\n Objectives</div>\n<div>\n We sought to evaluate the safety, effectiveness and acceptability of the use of topical</div>\n<div>\n anaesthesia with ShangRing circumcision of men and boys 10 years of age and above.</div>\n<div>\n  </div>\n<div>\n Methods</div>\n<div>\n Participants were randomised 2:1 to receive topical or injectable anaesthesia. All</div>\n<div>\n participants underwent no-flip ShangRing circumcision. The primary outcome measure</div>\n<div>\n was pain. Secondary outcomes included ease of use of topical versus injectable</div>\n<div>\n anaesthesia, AEs and participant satisfaction.</div>\n<div>\n  </div>\n<div>\n Results</div>\n<div>\n Compared to the topical group, participants in the injectable group reported</div>\n<div>\n significantly more pain on administration of the anesthesia and at approximately 20</div>\n<div>\n minutes after the procedure. Sufficient anaesthesia with topical cream was not</div>\n<div>\n achieved in 21 (9.3%) cases and supplementary injectable anaesthesia was required.</div>\n<div>\n The AE rate was significantly (p<.01) lower in the topical (0%) vs. the injectable group</div>\n<div>\n (4.2%). The most common was pain during the post-operative period. All AEs were</div>\n<div>\n managed conservatively and resolved without sequeale. 96.7% of participants were</div>\n<div>\n satisfied with the appearance of the healed penis and 100% would recommend the</div>\n<div>\n ShangRing to others. All seven male circumcision providers involved in the study</div>\n<div>\n preferred topical to injectable anaesthesia.</div>\n<div>\n  </div>\n<div>\n Conclusions</div>\n<div>\n Our results demonstrate the safety, improved clinical experience, effectiveness, and</div>\n<div>\n acceptability of the use of topical anaesthesia in ShangRing circumcision using the noflip</div>\n<div>\n technique. Topical anaesthesia is an important alternative and has the potential to</div>\n<div>\n increase demand for VMMC while decreasing the risk of needlestick injuries.</div>\n
      • implication_results(null)
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      • modified2018-10-10 18:29:03
      • created2015-01-19 09:07:49
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        • id257
        • application_id379
        • given_nameMark
        • middle_name
        • family_nameBarone
        • qualificationDVM, MS
        • professional_address440 Ninth Avenue, 12th Floor, New York, New York
        • telephone+1 212 561 8084
        • emailmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
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        • application_id379
        • county_id43
        • site_nameHoma Bay Level IV hospital
        • physical_addressHoma Bay town,
        • contact_details0723 886 261
        • contact_personDr. Raymond Otieno
        • site_capacity(null)
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        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
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          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
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        • county_id3
        • site_nameVipingo Health Centre
        • physical_addressVipingo
        • contact_details0722 235 433
        • contact_personJudy Kinya
        • site_capacity(null)
        • misc(null)
        • created2015-01-19 11:11:35
        • modified2015-01-27 18:25:09
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          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
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        • id195
        • application_id379
        • sponsorEngenderHealth
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        • contact_personMark Barone
        • address440 Ninth Avenue, New york
        • telephone_number+1 (206) 709-3100
        • fax_number
        • cell_number+1 (206) 709-3100
        • email_addressmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
      • 1(array)
        • id196
        • application_id379
        • sponsorWeill Cornell Medical College
        • sponsor_type(null)
        • contact_personProf. Phillip Li
        • address1300 York Avenue . New York, NY 10065
        • telephone_number+1 (212) 746-5454
        • fax_number
        • cell_number+1 646 341 0033
        • email_addresspsli@med.cornell.edu
        • created2015-01-19 11:48:26
        • modified2015-01-27 18:25:09
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Included Files

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    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php