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1 Clinical Trial Details (PDF Generation Date :- Sat, 30 Jun :58:19 GMT) CTRI Number CTRI/2010/091/ [Registered on: 26/07/2010] - Last Modified On 25/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial A clinical trial to study the effects of Metronidazole gel (Zydus) Versus MetroGel-Vaginal of Graceway Pharmaceuticals, in the treatment of patients with bacterial vaginosis. A multicentric, prospective, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with Metronidazole vaginal gel 0.75% (MetroGel-Vaginal ) of Graceway Pharmaceuticals, LLC in the treatment of bacterial vaginosis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) METVG PROT Designation Affiliation Protocol Number Details of Principal Investigator Dr RH Jani Senior Vice President Phone Fax Designation Affiliation Zydus Cadila House Plot No 360 TPS 5 Service Road Vile Parle East Mumbai MAHARASHTRA rhjani@zyduscadila.com Details Contact Person (Scientific Query) Dr RH Jani Sr V P Phone Fax Designation Affiliation Zydus Cadila House Plot No 360, TPS 5 Service Road Vile Parle (East) Mumbai MAHARASHTRA rhjani@zyduscadila.com Details Contact Person (Public Query) Dr R H Jani Sr. Vice President, Clinical R&D Zydus Cadila House Plot No 360 TPS 5 Service Road, Vile Parle East Mumbai MAHARASHTRA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Phone Fax > Zydus Pharmaceuticals (USA) Inc Type of Sponsor NIL List of Countries of Principal Investigator Dr Kanan Avinash Yelikar Source of Monetary or Material Support Primary Sponsor Details Cadila Healthcare Ltd. Satelite Road Ahmedabad, gujarat Pharmaceutical industry-n of Site Site Phone/Fax/ Government Medical College Department of Obstetrics & Gynecology,Panchakki Road Aurangabad BIHAR Dr Manju Shukla K.K. Hospital 187/88, Nabi Bullah Road,River Bank Colony Lucknow UTTAR PRADESH Dr Namita Agrawal Life Care Hospital Cons. Gynaecologist & Medical Director,98, Cantt Road Lucknow UTTAR PRADESH Dr Viraj Jaiswal Mayo Hospital Sultania Road,Opp. SBI Bhopal MADHYA PRADESH Dr BI Patel Shreeji Hospital Meghaninagar Ahmadabad GUJARAT Dr P M Gopinath Sooriya Hospital 1/1, Arunachalam Road,Saligramam Chennai TAMIL NADU Dr Shashi Arora Yashoda Super Speciality Hospital H-1, Kaushambi, Ghaziabad UTTAR PRADESH drkanany@yahoo.co.in sukladrmanju@rediffma il.com lch_lko@yahoo.co.in mayohospital@yahoo.c om bipatel1@hotmail.com dgopinath@yahoo.com drshashi_arora@hotmai l.com of Approval Status Date of Approval Is Independent Ethics? Bina Bhatt,Independent Ethics,Ahmedabad Dr Jignesh Shah,Independent page 2 / 6

3 Dr Manju Shukla,Independent Dr P M Gopinath,Independent Ethics committee,aditya Dr Poornima M,Ethics Approved 15/04/2011 Yes committee of st Marthas hospital Dr Rajeshwari Approved 12/04/2011 Yes Patil,Independent ethics committee,aditya Dr Rekha Bhandari,Independent Ethics committtee Aditya Dr Rekha Khandelwal,I ndependent Ethics committee,aditya Approved 12/04/2011 Yes Dr Shahsi Arora,Independent Dr Sheela Mane,Independent Ethics commiteee,aditya Dr Vinita Agarwal,Independent Ethics,Aditya Dr. Jyoti Unni,Jahangir Clinical development centre Ethics Dr. Mukesh Chandra,Independent Ethics -Aditya Dr.C P Sudha, Institutional Ethics of Kempegowda Institue of medical sciences Dr.Chandravati, Independent Ethics Commitee Aditya-Ahmedabad Dr.Chandrika,Independ ent Ethics -A ditya,ahmedabad Dr.Dilip Kamath,Nirmaya Hospital Ethics Dr.K Nagasundri,Indep endent Ethics Approved 28/01/2011 Yes Approved 17/03/2011 Yes Approved 05/04/2011 Yes Approved 12/04/2011 Yes page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Aditya-Ahmedabad Dr.Kanan Yelikar,Instituional Ethics,Govt Medical College,Aurangabad Dr.Kurus Koyaji,KEM hospital Research centre Dr.Mahinder Ahuja,Independent Ethics,Adity a-ahmedabad Dr.Manju Jilla,Jilla Hospital Human Ethics Dr.Meenakshi Rakolia,Independent Ethics Committe-Aditya -Ahmedabad Dr.N Sundri,M.S Ramiah Medical College and Teaching hospital and Ethical review board Approved 20/04/2011 Yes Approved 12/03/2011 Yes Approved 24/03/2011 Yes Approved 10/02/2011 Yes Dr.Namita Agarwal,Independent Ethics Committe-Aditya, Ahmedabad Approved 20/05/2011 Yes Dr.Nivedita Pawar,Independent -Ahmedabad Jagdip Shah,Pioneer independent Ethics Committe Approved 16/03/2011 Yes Jayesh Amin,Indepenent Ethics Committe Aditya-Ahmedabad Status Date Approved/Obtained 10/12/2009 Health Type Patients Condition Bacterial vaginosis Type Details Intervention Comparator Agent Metronidazole vaginal gel (Zydus), 0.75% MetroGel-Vaginal gel (Graceway Pharmaceuticals, LLC), 0.75% 5g containing approximately 37.5 mg of metronidazole once daily at bedtime for 5 consecutive days. Intravaginal 5g containing approximately 37.5 mg of metronidazole once daily at bedtime for 5 consecutive days. Intravaginal Comparator Agent Placebo 5g of placebo once daily at bedtime for 5 consecutive days. page 4 / 6

5 Inclusion Criteria Age From Age To Gender Details Year(s) Year(s) Female Inclusion Criteria Intravaginal 1. Subjects must provide the written informed consent prior to any study related procedure being performed. 2. Subjects must be 18 years of age or older with no known medical conditions that, in the investigator?s opinion, may interfere with study participation. 3. Women of childbearing potential must have a negative urine pregnancy test result upon entry into the study. 4. Subjects must agree to abstain from sexual intercourse throughout the first seven days of the study. Following the first 7 days, subjects must agree to use adequate contraceptive measures except using lubricated condom when engaging in sexual intercourse. 5. Subjects must agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays, spermicides, lubricated condoms, tampons, and diaphragms). 6. Women with regular menstruation and visiting the trial centre from 5th day to 20th day of the cycle or post menopausal women (defined as women with absence of menstruation for at least last 1 year), or women with surgical menopause (oophorectomy, hysterectomy) 7. Subjects must be willing to abstain from alcohol ingestion during first seven days of the study. 8. Female subjects must have a clinical diagnosis of bacterial vaginosis satisfying the following criteria: a) Off-white, thin, homogeneous discharge with little if any inflammation b) ph of vaginal fluid greater than 4.5, using ph paper that measures from 4.0 to 6.0 c) Positive?whiff? test for amine odour after addition of 10% KOH d) More than or equal to 20% Clue cells of the total epithelial cells on microscopic examination of the saline?wet mount? A Gram?s stain slide with Nugent score more than equal to 4 Exclusion Criteria Details Exclusion Criteria 1. Known or suspected nonbacterial causes of vulvovaginitis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, active Herpes simplex, or human papilloma virus, or any other vaginal or vulvar condition, which in the investigator?s opinion, would confound the interpretation of clinical response). 2. Subject with history of menstrual irregularity in last 3 months. 3. Receipt of antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to dosing. 4. Receipt of disulfiram within 14 days prior to dosing. 5. Previous hypersensitivity reaction to metronidazole in any form or to any form of parabens. 6. History of significant hepatic and/or renal insufficiency 7. Subjects with history of gastrointestinal disease using cimetidine or with history of mental illness using lithium. 8. History of significant cardiovascular disorders 9. History of primary or secondary immunodeficiency. 10. Plans to be treated during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma. 11. Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months. page 5 / 6

6 Powered by TCPDF ( PDF of Trial Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Participant, Investigator and Outcome Assessor Blinded 12. Concurrent anticoagulation therapy with Coumadin (e.g. warfarin). 13. Concurrent use of systemic corticosteroids or systemic antibiotics. 14. Participation in another clinical trial or having taken an experimental drug within 30 days prior to the study entry. 15. Unwilling or unable to comply with the protocol requirements. Primary Outcome Outcome Timepoints The primary efficacy endpoint is the therapeutic cure, which requires both clinical cure and Nugent score of 0-3 at test of cure visit days Secondary Outcome Outcome Timepoints The secondary efficacy endpoints are a)clinical cure rate b)nugent score on Gram stain i.nugent score less then 4 is bacteriological cure ii.nugent score? 4 is bacteriological failure c)time to resolution of symptoms days Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=670 Sample Size from =670 01/02/2011 No Date Specified Years=1 Months=6 Days=0 Not Applicable Other (Terminated) None This will be a multicentre, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Metronidazole gel 0.75% (Zydus) with MetroGel-Vaginal Gel, 0.75% (Graceway Pharmaceuticals, LLC) in the treatment of bacterial vaginosis. page 6 / 6