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1 Clinical Trial Details (PDF Generation Date :- Mon, 21 Jan :37:04 GMT) CTRI Number Last Modified On 06/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/03/ [Registered on: 13/03/2014] - Trial Registered Prospectively Interventional Drug Other A Clinical trial intended to compare two formulations of Diclofenac sodium topical Gel 1% along with placebo, in patients with knee osteoarthritis. A Multi-Center, Double-Blind, Vehicle-Controlled, Parallel-Group Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren Gel (Diclofenac Sodium Topical Gel) 1% in the Treatment of Subjects with Osteoarthritis of the Knee 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) AM-DCG-001 version 3 dated Name Designation Affiliation Address Protocol Number Details of Principal Investigator Dr Nikunj Patel Executive Vice President, Global Clinical Affairs Amneal Pharmaceuticals Phone Fax Name Designation Affiliation Address Amneal Pharmaceuticals corporate office, , 5th Floor, Venus atlantis, nr. Safal Pegasus, Prahladnagar nikunj@amneal.com Details Contact Person (Scientific Query) Dr Prayag Shah Assistant General Manager, Global Clinical Affairs Amneal Pharmaceuticals Phone Fax Name Designation Affiliation Address Amneal Pharmaceuticals Co. (I) Pvt. Ltd., Corporate Headquarters, , 5th floor, Venus Atlantis, Nr. Safal Pegasus, Prahladnagar, Ahmedabad prayags@amnealindia.com Details Contact Person (Public Query) IrshadulHaque General Manager, Global Clinical Affairs Amneal Pharmaceuticals Amneal Pharmaceuticals Co. (I) Pvt. Ltd., Corporate Headquarters, , 5th floor, Venus Atlantis, Nr. Safal Pegasus, Prahladnagar, Ahmedabad page 1 / 12

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Amneal Pharmaceuticals Name Source of Monetary or Material Support Primary Sponsor Details Amneal Pharmaceuticals Address 85 Adams Avenue Hauppauge, NY Type of Sponsor Name NIL List of Countries Name of Principal Investigator Dr Pardha Saradhi Dr Raja Pandian Dr Rajesh Kumar Dulani Dr Ankit Balkrishna Kedia Dr Bartakke Girish Chandra Dyaneshwar Other [US based generic pharmaceutical company] Address NIL Name of Site Site Address Phone/Fax/ Andhra Medical College Andhra Medical college, Orthopedics, Clinical Research division, Ground Floor, Room. 17 and 18, Clinical Reserch Area, Unit -1 Vishakapatnam , A.P, Visakhapatnam ANDHRA PRADESH Apollo Specialty Hospitals AVBR Hospital & Jawaharlal Nehru Medical College BJ Medical College & Civil Hospital BJ medical college & Sassoon General Orthopaedics, Room. 65, Lake View Road, K. K. Nagar, Madurai , Tamil Nadu, Madurai TAMIL NADU Orthopaedics, Datta Megha Instititute of Medical Sciences, Wardha, Nagpur Nagpur B.J Medical College & Civil Hospital, Orthopedics, Wing 2, Ground Floor, Ahmedabad BJ Medical College Sassoon General mail.com m page 2 / 12

3 Hospital Dr D Raj Kiran CARE Hospitals Orthopaedics, Road. 01, Banjara Hills, Hyderabad Andhra Pradesh Hyderabad ANDHRA PRADESH Dr Bharath Mody Dr Somesh Prakashbhai Singh Dr Samprassad S Nadkarni Dr Ravindran Dr Sajal R Mitra Centre for Knee and Hip Surgery GMERS Medical College & Civil Hospital Goa Medical College Government Medical College Government Medical College and Hospital Hospital, Dept of girishbartakke@rediffm Orthopedics,Orthopedic ail.com Building, 2nd Floor, HOD Room, Sassoon Road, Near Railway Station, Pune Pune Centre for Knee & Hip Surgery, Deaprtment of Orthopaedics, Clinical Research Division, 3rd Floor, Room. 10, Clinical Research Department, 101/103, Akashganga Building, Near Vanijya Bhavan, Race Course Circle, Vadodara , Gujarat, Welcare Hospital, Nera Mile Motors, Atladara, Vadodara Vadodara Dept. of Orthopedics, Ground floor, Room. 5, Sola, Near Gujarat High Court, S. G. Highway, Ahmedabad , Gujarat. Dept. Of Orthopedics, Faculty Block, Ground Floor, Goa Medical College, Bambolim, Tiswadi Goa-, PO Box Bambolim.: rth Goa GOA Orthopaedics, Ward. 24, Kozhikode, Kerala Kozhikode KERALA Government Medical College and Hospital, Dept of Orthopedics, OT-E, Opp. Ward. 26, 1st Floor Nagpur docterrajkiran@gmail.c om mail@centreforkneesur gery.com drsomeshsingh@yahoo.com sambnadkarni@yahoo. co.in raveendranmk@gmail.c om sajalmitra2007@yahoo. co.in page 3 / 12

4 Dr Narendra V Kothari Dr Alok Shobhan Datta Hatkesh Healthcare Foundation Institute of Post Graduate Medical Education and Research (IPGMER) Nagpur Hutkesh Healthcare Foundation, Deaprtment of Orthopaedics, Clinical Research Divison, 2st Floor, Research Room, Opp. Bhutnath Temple,Junagadh, Junagadh Orthopedics, Ronald Ross Building, Ground Floor, # 244, AJC Bose Road, Kolkata Kolkata WEST BENGAL hatkesh.research@gma il.com aloksobhondatta@gmai l.com Dr Smruti Ramteke Jasleen Hospital Jasleen Hospital,Dept of Orthopedics, Clinical Research Division, 1st sramteke@rediffmail.co Floor, Clinical Research m Room, Opp. Big Bazar, Panchashil Square, wardha Road, Nagpur Nagpur Dr Krishna Subrahmanya Kumar Pannala Dr Surendra Umesh Kamath Kamineni Hospitals Kasturba Medical College Hospital orthopaedics, OPD room number 12, L. B. Nagar, Hyderabad , Andhra Pradesh, Hyderabad ANDHRA PRADESH Deaprtment of Orthopaedics, Ground Floor, OPD. 12, Attavar, Mangalore , Karnataka, Dakshina Kannada KARNATAKA Dr Ashok Kumar King George Hospital Orthopedics, Unit - II, OP. 10, King George Hospital, Andhra Medical College, Visakapatnam Visakhapatnam ANDHRA PRADESH Dr Ashish Kumar King George Medical University subri_pannala@yahoo. co.in skamath3@hotmail.co m Ashok_ortho59@rediff mail.com Orthopedic Surgery, Lal Bahadur Shastri drashish_kumar20202 Bhawan, 4th page 4 / 12

5 Lucknow Lucknow UTTAR PRADESH Dr Bhandankar KLES Medical College KLES Dr. Prabhakar Kore Hospital and Medical Research Center Dept. Of Joint Replacement and Anthroscopy, Nehru Nagar, Belgaum,Karnataka Belgaum KARNATAKA Dr Veeravalli Sarath Chandra Mouli Prof Arvind Gore Gaonkar Dr Naresh Shetty Dr Kunal Bhalla Dr Rajiv Gupta Krishna Institute of Medical Sciences Ltd Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital M. S. Ramaiah Medical College & Hospitals M. V. Hospital and Research Centre Malpani Multispeciality Hospital Orthopaedics, /1, Block 3, Room. 1, Minister Road, Secunderabad Hyderabad ANDHRA PRADESH Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Orthopaedics, Pharmacology, College Building, Second Floor, Room. 2, Dr. B. R. Ambedkar Road, Sion, Mumbai Mumbai Orthopaedics, MSRIT Post, New BEL Road, Bangalore Karnataka Bangalore KARNATAKA rajendra.bhandankar@ gmail.com sarath10@hotmail.com abgoregaonkar@gmail. com naresh8@hotmail.com Deaprtment of Orthopaedics, 314/30, Ground Floor, OP. kunalicious_kunal@yah 2, Mirza Mandir Chowk, oo.com Lucknow Uttar Pradesh Lucknow UTTAR PRADESH Malpani Multispeciality Hospital, Orthopaedics,Clinical Research Division, Basement Clinical Research Facility, SP-6, Road -1, V.K.l Area, Sikar Road, Jaipur Jaipur drrajivg77@gmail.com page 5 / 12

6 Dr Suresh kumar Kejriwal Dr Marula Siddappa Dr Sushil H Mankar Dr Vijay Goni Dr Gaurav Jugalkishore Rathi Dr Sandip Roy Dr Parag Sancheti Medical College & Hospital RAJASTHAN Orthopedics, Emergency building, ground floor, Room. 6, College Street, Kolkata Kolkata WEST BENGAL Mysore medical college K R Hospital, Mysore Medical College & Research Institute, Orthopaedics, Mysore Mysore KARNATAKA NKP salve Institute of Medical Sciences and Lata Mangeshkar Hospital Post Graduate Institute of Medical Institute of Medical Education and Research (PGIMER) Rathi Hospital RG Kar Medical College Sancheti Institute for Orthopaedics and Rehabilitation dr_suresh01@yahoo.co m gmsortho@gmail.com Deaprtment of Orthopaedics, 1st Floor, Digdoh Hills, Hingna drshmankar@rediffmail. road, Nagpur, com Maharashtra- Nagpur Post Graduate Institute of Medical Education & Research (PGIMER), Dept. of Orthopedics, Ground Floor, Chandigarh , Chandigarh CHANDIGARH vijaygoni@gmail.com Rathi Hospital, Orthopaedics, Clinical drgjrathi@yahoo.co.in Reasearch Division, Basement Clinical Research Area, Nr Anupam Shopping Centre, Opp Mahabaleshwar Soc, Nr Jodhpur Cross roads, Satellite, Ahmedabad , Gujarat, RG Kar Medical College & Hospital,Deaprtment of drskroy@hotmail.com Orthopaedics, Outdoor Building, Room. 106, 1, Kshudiram Bose Sarani, Kolkatta Kolkata WEST BENGAL Sancheti Institue for Orthopaedics and Rehabilitation, Dept. of parag@sanchetihospita page 6 / 12

7 Details of Ethics Committee Dr Harshal Kalariya Dr Neel Bhavsar Dr Joe Joseph Cherian Shree Giriraj Multispecilaity Hospital Smt NHL Municipal Medical College St. Johns Medical College Hospital Orthopedics, Clinical Research Division, 1st Floor, Sancheti Research Department, 16 Shivaji Nagar, Pune Maharashtra Pune Shree Giriraj Multispeciality Hospital, Dept. of Orthopedics, Clinical Research Division, Basement Clinical Research Facility, 150 Feet Ring Road, 27-Navjyot Park Main Road, Amin Marg Cross Road, Rajkot, Gujarat Rajkot Smt NHL Municipal Medical College, Orthopaedics, Ortho OPD Building, Unit-A, Near Trauma Centre, Room. 42, Ellisbridge, Ahmedabad Orthopedics, 3rd Floor, Sarjapur Road, Korama ngala,banglore Bangalore KARNATAKA Dr Gurava Reddy Sunshine hospital Sunshine Hospitals, Orthopaedics, Room. 3, P.G. Road, Paradise, Secunderabad Hyderabad ANDHRA PRADESH l.org harshalkalaria@gmail.c om neelmb@yahoo.com cherianjoe71@gmail.co m guravareddy@gmail.co m Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? B.J.Medical College Ethics Committee Ethics Committee Centre for Knee Surgery (ECCKS) Ethics committee, Apollo Specialty Hospitals Approved 15/04/2014 Approved 24/01/2014 Approved 26/02/2014 Ethics committee, KLE Date Specified page 7 / 12

8 University Ethics committee, M. S. Ramaiah Medical College & Hospitals Hatkesh Healthcare Foundation Ethics Committee Institutional Ethics Committee - Krishna Institute of Medical Sciences Ltd. Institutional Ethics Committee - Malpani Multispeciality Hospital Institutional Ethical Board, St. Johns Medical College Hospital committee & Human Resource LTMMC & GH Staff and Research Society committee (IEC) M. V. Hospital and Research Centre committee BJ Medical College & Civil Hospital committee for Human Research, Medical College committee GMERS Medical College committee Goa Medical College committee of King George Hospital committee of King George Medical University Approved 22/02/2014 Approved 05/02/2014 Date Specified Approved 29/09/2013 Approved 08/01/2014 Approved 28/02/2014 Approved 12/01/2014 Approved 27/03/2014 Date Specified Approved 02/05/2014 Approved 10/03/2014 Approved 13/02/2014 Date Specified committee, Andhra Medical college, Vishakapatnam , A.P - Approved 20/03/2014 committee, CARE Convergence centre committee, DMIMS Date Specified Date Specified page 8 / 12

9 Regulatory Clearance Status from DCGI (DU) Sawangi (Meghe) Wardha committee, Government Medical College and Hospital, Nagpur Approved 20/05/2014 committee, Govt. medical college, Kozikhode committee, Institute of Post Graduate Medical Education and Research committee, Kamineni Hospitals Pvt Ltd committee, Mysore Medical College & Research Institute committee, NKP salve Institute of Medical Sciences committee, PGIMER, Chandigarh , committee, RG Kar Medical College committee, Smt NHL Municipal Medical College committee, Sunshine hospital Jasleen Hospitals Ethics Committee Manipal University Ethics Committee Approved 03/03/2014 Approved 16/04/2014 Approved 04/03/2014 Approved 21/03/2014 Approved 26/02/2014 Date Specified Date Specified Date Specified Approved 18/04/2014 Approved 10/03/2014 Approved 17/03/2014 Rathi Ethics Committee Approved 27/02/2014 Sancheti Institute for Orthopaedics and Rehabilitation Institutional Board Shree Giriraj Hospital Research Ethics Committee Status Approved 03/03/2014 Approved 04/02/2014 Date Approved/Obtained 11/12/2013 Health Condition / Health Type Condition page 9 / 12

10 Problems Studied Patients Patients with osteoarthritis of the knee Intervention / Comparator Agent Inclusion Criteria Type Name Details Intervention Generic Diclofenac Sodium Topical Gel It is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (Therapeutic Equivalence Study.Each patient will apply 1 dose of 4 gram for 4 times a day for 28 days Intervention Vehicle (Placebo) Vehicle (Placebo) of Diclofenac Sodium Topical Gel, 1%. Each patient will apply 1 dose of 4 gram for 4 times a day for 28 days Comparator Agent 1% Voltaren Gel Voltaren Gel is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.each patient will apply 1 dose of 4 gram for 4 times a day for 28 days Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study. 2.Healthy, ambulatory male or non-pregnant female subjects aged? 35 years with a clinical diagnosis of OA of the knee including: Presence of at least three (3) of the American College of Rheumatology (ACR) criteria (age? 50; stiffness lasting Symptoms for at least 6 months prior to screening, AND Knee (not referred) pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.), AND The pain in the target knee required the use of NSAIDs or paracetamol/ acetaminophen (topical or oral treatments). 3.Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease. 4.After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement (POM) for target knee, defined as a baseline score of? 50 mm on a mm Visual Analog Scale (VAS) immediately prior to randomization, AND a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization. 5.If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom + spermicide, IUD, oral, transdermal, injected or implanted hormonal contraceptives). 6.Able to tolerate rescue medication with paracetamol/acetaminophen. page 10 / 12

11 7.Willing and able to comply with the study requirements. Exclusion Criteria Details Exclusion Criteria 1.Pregnant or lactating or planning to become pregnant during the study period. 2.X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease. 3.History of OA pain in the contralateral knee requiring medication (OTC or prescription) within 1 year prior to screening. 4.After discontinuing all pain medications for at least 7 days, has a baseline score of? 20 mm on a mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization. 5.History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia. 6.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. 7.History of gastrointestinal bleeding or peptic ulcer disease. 8.Use of warfarin or other anticoagulant therapy within 30 days of study randomization. 9.Elevated transaminases at screening (AST or ALT more than 2 times the upper limit of normal at screening visit). 10.Use of ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within 30 days of study randomization. 11.Concomitant use of corticosteroids (any formulation) or use within 30 days of study randomization. 12.Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis (max 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. 13.Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID). 14.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study. 15.Receipt of any drug as part of a research study within 30 days prior to screening. 16.Previous participation in this study. 17.Any use between screening and baseline of a treatment or medication that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs). 18.Recent history of major knee injury or surgery. 19.Known history of positive HIV. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Other Outcome Assessor Blinded Primary Outcome Outcome Timepoints The primary efficacy endpoint will be the mean change from baseline to week 4 in the WOMAC pain score Assessment of WOMAC scale from Day 1 to Day 28 Secondary Outcome Outcome Timepoints Target Sample Size not applicable Total Sample Size=1176 Sample Size from =1176 not applicable page 11 / 12

12 Powered by TCPDF ( PDF of Trial 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 24/03/2014 Date Specified Years=1 Months=0 Days=0 t Applicable Closed to Recruitment of Participants t Applicable This will be randomized, multi-center, double blind, vehicle controlled, parallel group study to be performed at approximately 35 study sites located in. The randomized subjects will be enrolled in a 1:1:1 ratio.the primary efficacy end point in the study is the mean change from baseline to week 4 in the WOMAC pain score (pain score= 0 to 20), which will be determined by the subjects responses to five questions (S1-S5) using a 5-point likert scale (i.e., none=0, mild=1, moderate=2, serve=3, extreme=4). The questions pertain to the amount of pain the subject is currently experiencing in the target knee [i.e., How much pain do you have when walking on a flat surface (S1), Going up or down stairs (S2), At night while in bed (S3), Sitting or lying (S4), Standing upright (S5)] page 12 / 12