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Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 19:36:37 GMT)
CTRI Number CTRI/2017/04/008304 [Registered on: 06/04/2017] - Trial Registered Prospectively Last Modified On 21/03/2018 Post Graduate Thesis No Type of Trial BA/BE Type of Study Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Bioequivalence study with clinical endpoint of generic diclofenac gel with Voltaren® gel in patients with osteoarthritis of knee. Scientific Title of A Randomized, Double blind, Three-arm, Parallel, Placebo-controlled, Clinical Study to Evaluate the Study Bioequivalence using Clinical Endpoint of Diclofenac Sodium Gel, 1% (Mylan Inc.) versus Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis Consumer Health, Inc.) in Patients with Osteoarthritis (OA) of the Knee. Secondary IDs if Any Secondary ID Identifier CRL081620 version 1.0 dated 06 Dec 2016 Protocol Number MYL-1601N-3002 version 1.0 dated 06 Dec Protocol Number 2016 MYL-1601N-3002 version 1.1 dated 03 May Protocol Number 2017 Details of Principal Details of Principal Investigator Investigator or overall Name Dr Dharmesh Domadia Trial Coordinator (multi-center study) Designation Associate Vice President -Global Clinical Operation Affiliation Cliantha Research Ltd. Address Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev, Ahmedabad 380054 Gujarat India Ahmadabad GUJARAT 380054 India Ahmadabad GUJARAT 380054 India Phone 9879590828 Fax 0796613549 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Prasanna Ganapathi Query) Designation General Manager - Clinical R & D Affiliation Mylan Pharmaceutical Pvt. Ltd. Address Mylan Pharmaceuticals Pvt Ltd. Prestige Platina, Block 3, Kadubeesanahalli Village, Outer Ring Road, Bangalore – 560087, INDIA Bangalore KARNATAKA 560087 India Phone 8066728952 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mr Foram Madhu Designation Project Manager
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Affiliation Cliantha Research Ltd. Address Garden View Corporate House No. 8 Opp. AUDA Garden, Bodakdev, Ahmedabad 380054 Gujarat India Ahmadabad GUJARAT 380054 India Ahmadabad GUJARAT 380054 India Phone 9712915985 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Mylan Laboratories Pvt Ltd Plot No: 564/A/22, Road No: 92, Jubilee Hills, Hyderabad – 500033, Telangana, India Primary Sponsor Primary Sponsor Details Name Mylan Laboratories Pvt Ltd Address Plot No: 564/A/22, Road No: 92, Jubilee Hills, Hyderabad – 500033, Telangana, India. Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Rajesh Prajapati Ajanta Research Centre Ajanta Research 9559782773 Centre, Ajanta Hospital and IVF Centre, [email protected] Department of om Orthopaedics, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow 226005, Uttar Pradesh Lucknow UTTAR PRADESH Dr Amit Patel Anand Multispeciality Department of 9824455237 Hospital Orthopaedics, Anand Multispeciality Hospital, [email protected] B-Tower, Sundervan Complex, Near Gorwa ITI, Gorwa, Beside IOCL petrol pump, Vadodara-390016, Gujarat Vadodara GUJARAT Dr Kaushal Anand B.J Medical College & Orthopaedic 9909013564 Civil Hospital Department, B.J Medical College & Civil kaushal87anand@gmai Hospital, Asarva, l.com Ahmedabad-380016, Gujarat Ahmadabad GUJARAT
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Dr Pramodini Vasant Bhaktivedanta Hospital BhaktiVedanta Hospital 9820317030 Shankaran and Medical Research and Research Institute, Srishti Complex, shankarankrishnan@ya Bhaktivedanta Swami hoo.com Marg, Mira Road East, Thane, Maharashtra-401107 Thane MAHARASHTRA Dr Amit Kale BJ medical college & BJ Medical College 9423585027 Sassoon General Sassoon General Hospital Hospital, Dept of [email protected] Orthopedics,Orthopedic om Building, 2nd Floor, HOD Room, Sassoon Road, Near Railway Station, Pune - 411001 Pune MAHARASHTRA Dr Somesh GMERS Medical Dept. of Orthopaedics, 9825370446 Prakashbhai Singh College & Civil Hospital GMERS Medical College & Civil Hospital drsomeshsingh@yahoo , Near Gujarat High .com Court, S. G. Highway, Ahmedabad 380061, Gujarat Ahmadabad GUJARAT Dr M K Ravindran Government Medical Government Medical 9447023525 College College, Department of Orthopaedics, Ward [email protected] No. 24, Kozhikode, om Kerala-673008 Kozhikode KERALA Dr Sajal R Mitra Government Medical Government Medical 9373114929 College and Hospital College and Hospital , Dept of Orthopedics, sajalmitra2007@yahoo. OT-E, Opp. Ward No. co.in 26, 1st Floor Nagpur-440003, Maharashtra Nagpur MAHARASHTRA Dr Mohammed Asharaf Governmentt T.D Department of 04772251611 Mammatharayan Illah Medical College Orthopaedics, Governmentt T.D [email protected] Medical College, m Vandanam, Alappuzha, Kerala 688005 Alappuzha KERALA Dr Tholgapiyan T Govt Stanley Medical Dept. of Orthopaedic 9048104673 College & Hospital Surgery, Govt Stanley Medical College & stanelyresearch16@gm Hospital, Old Jail Road, ail.com Royapuram, Chennai - 600001, Tamil Nadu Chennai
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TAMIL NADU Dr Eknath Pawar Grant Government Department of 8551996777 Medical College & Sir J Orthopaedics, Grant J Group of hospital Government Medical drpawared2003@yahoo College & Sir J J Group .co.in of hospital, Byculla, Mumbai 400008, Maharashtra Mumbai MAHARASHTRA Dr Jagannath Sahoo IMS and SUM Hospital IMS and SUM Hospital 9439523875 Department of Orthopaedics K-8, [email protected] Kalinga Nagar, Bhubaneswar - 751003, Odisha Cuttack ORISSA Dr Ananda Kisor Pal Institute of Post Department of 9831093244 Graduate Medical Orthopaedics, # 244, Education and Institute of Post [email protected] Research (IPGMER) Graduate Medical Education and Research (IPGMER), AJC Bose Road, Kolkata 700020, West Bengal Kolkata WEST BENGAL Dr Smruti Ramteke Jasleen Hospital Department of 9823514680 Orthopaedics, Jasleen Hospital, Opp. Big [email protected] Bazar, Panchsheel m Square, Dhantoli, Nagpur-440012, Maharashtra Nagpur MAHARASHTRA Dr A Ramakrishnam King George Hospital Department of 9885093386 Naidu Orthopedics, Unit - II, OP No. 10, King [email protected] George Hospital, Andhra Medical College, Visakapatnam-530002, Andhrapradesh. Visakhapatnam ANDHRA PRADESH Dr Ashish Kumar King George Medical Department of 9415020202 University Orthopaedic Surgery, King George Medical drashish_kumar20202 University, Lal Bahadur @yahoo.com Shastri Bhawan, Nabiullah Road, RALC campus, Lucknow 226018, Uttarpradesh Lucknow UTTAR PRADESH Dr Arvind Goregaonkar Lokmanya Tilak Lokmanya Tilak 9821351787
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Municipal Medical Municipal Medical College & General College & General [email protected] Hospital Hospital, Department of Orthopaedics, College Building, Second Floor, Room No. 2, Dr. B. R. Ambedkar Road, Sion, Mumbai - 400022 Mumbai MAHARASHTRA DrKunal Bhalla M.V. Hospital & M.V. Hospital & 8744009726 Research Centre Research Centre, 314/30, Mirza Mandi, kunalicious_kunal@yah Chowk, oo.com Lucknow-226003, UP Lucknow UTTAR PRADESH Dr Sudipto Das Medica Super 127, Orthopaedic 7044076893 Speciality Hospital Department, Medica Super Speciality sudipto.das@medicasy Hospital, E. M. Bypass, nergie.in Mukundapur, Kolkata 700099, West Bengal Kolkata WEST BENGAL Dr Jaykrushna Soni Medistar Multispeciality Department of 9879291135 Hospital Orthopaedics, Medistar Multispeciality Hospital, drjaykrishnasoni@yaho Trimurti Avenue, o.co.in Medistar cross road, NH8, Industrial Area, Himmatnagar-383001, Sabarkantha, Gujarat. Sabar Kantha GUJARAT Dr Paramesh K C Mysore Medical College K. R. Hospital, 9343055819 and Research Institute Department of Orthopaedics, Mysore parameshkennal@gmai Medical College and l.com Research Institute, Mysore, Karnataka-570001 Mysore KARNATAKA Dr Sushil Mankar NKP Salve, Institute of NKP Salve, Institute of 9422108284 Medical sciences and Medical sciences and 07104-232905 Lata Mangeshkar Lata Mangeshkar, [email protected] Digdoh Hills, Hingna m Road, Nagpur - 440019, India Nagpur MAHARASHTRA Dr Awdhesh Kumar OM Research Center, SA-17/3, P-4, Sri 9453015238 Yadav OM Surgical Center & Krishna Nagar, Paharia, 0542-2588849 Maternity Home Ghazipur Road, awadhesh2083@gmail. Varanasi-- 221007, com Uttar Pradesh, India Varanasi UTTAR PRADESH
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Dr K Ramachandra Omega Hospital Omega Hospital, 9448452593 Kamath Mahaveer Circle, Kankanady, Mangalore [email protected] - 575002, Karnataka m Dakshina Kannada KARNATAKA Dr Niranjan Tadvi Parul Sevashram Orthopaedic 9879585846 Hospital Department, Parul Sevashram Hospital, dr.niranjantadvi@gmail. Parul university, PO com limda, Taluka Waghodia, Dist Vadodara 391760, Gujarat Vadodara GUJARAT Dr Vijay Goni Post Graduate Institute Post Graduate Institute 9815712727 of Medical Education & of Medical Education & Research (PGIMER) Research (PGIMER), [email protected] Dept. of Orthopaedics, sector 12, Chandigarh-160012 Chandigarh CHANDIGARH Dr Gaurav Jugalkishore Rathi Hospital Rathi Hospital, 9824015618 Rathi Department of Orthopaedics, Clinical [email protected] Reasearch Division, Basement Clinical Research Area, Nr Anupam Shopping Centre, Opp Mahabaleshwar Soc, Nr Jodhpur Cross roads, Satellite, Ahmedabad 380 015, Gujarat, India Ahmadabad GUJARAT Dr Jinesh Shah Riddhi Medical Nursing Orthopaedic 9879531832 Home Department, Riddhi Medical Nursing Home, [email protected] A-101, Jalaram plaza, m Near Jawahar chowk cross road, Maninagar, Ahmedabad 380008 Ahmadabad GUJARAT Dr Parag Sancheti Sancheti Institute for Department of 9823553333 Orthopedics & Orthopedics, Sancheti Rehabilitation Institute for Orthopaedic parag@sanchetihospita & Rehabilitation, 1st l.org floor, 16 Shivaji nagar Pune-411005, Maharashtra Pune MAHARASHTRA Dr Sharad Purohit Sanjivani Sanjivani 9879007908 Superspeciality Hospital Superspeciality Hospital Pvt. Ltd Pvt. Ltd,OPD room dr_sharadpurohit@hot
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Dept of orthopaedics 1, mail.com Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad-380015, Gujarat Ahmadabad GUJARAT Dr Mohan Desai Seth G.S Medical Orthopaedic 9892275697 College and KEM Department, Seth G.S. Hospital Medical College and drmohandesai@hotmail KEM Hospital, Parel, .com Mumbai- 400012, Maharashtra Mumbai MAHARASHTRA Dr Harshal Kalariya Shree Giriraj Shree Giriraj 9879883331 Multispeciality Hospital Multispeciality Hospital, 150 Feet Ring Road, [email protected] 27-Navjyot Park Main om Road, Amin Marg Cross Road, Rajkot, Gujarat 360005 Rajkot GUJARAT Dr Rajiv Daveshwar Sir Sayajirao General Dept. of orthopedics, 9427322493 Hospital and Medical Sir Sayajirao General College Hospital and Medical dr_rndaveshwar@yaho College, Anandpura, o.com Vadodara-390001, Gujarat Vadodara GUJARAT Dr Jiss Joseph Sree Narayana Institute Sree Narayana Institute 04844020255 Panakkal of Medical Science of Medical Science, Dept of Orthopedics, snims.research@gmail. Chalakka, com N.Kuthiyathodu, P.O. Eranakulam-683594, Kerala Ernakulam KERALA Dr Rupraj Pawar Supe Heart and Orthopaedic 9822060547 Diabetes Hospital & Department, Supe Research Centre Heart and Diabetes ruprajpawar@rediffmail. Hospital & Research com Centre, Opp Adharashram, Gharpure Ghat, Near Rungta High School, Ashok Stambh, Nashik 422002, Maharashtra Nashik MAHARASHTRA Dr Krishna Yashoda Hospital Department of 9246277646 Subrahmanya Kumar orthopaedics, Yashoda Pannala Hospital, Malakpet, subri_pannala@yahoo. Hyderabad 500 036, co.in Andhrapradesh Hyderabad
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ANDHRA PRADESH Dr Sanjib Kumar Yashoda Hospital Orthopaedic 9440180980 Behera Department, Yashoda Hospital, Behind Hari [email protected] Hara Kala Bhawan, m Secunderabad 500003, Andhrapradesh Hyderabad ANDHRA PRADESH Dr Sunil Dachepalli Yashoda Hospital Orthopaedic 9573424082 Department, Yashoda Hospital, Raj Bhavan dachepallisunil@gmail. road, Somajiguda, com Hyderabad 500 082, Andhra Pradesh Hyderabad ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Anand Institutional Approved 16/05/2017 No Ethics committee, Gorwa, Vadodara BhaktiVedanta Hospital Approved 19/05/2017 No Ethics Committee, Bhaktivedanta HEC office, 6th floor, BhaktiVedanta Hospital and Research Institute, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road(E), Thane, Maharashtra-401107, India. Clinical Research Approved 19/05/2017 No Ethics Committee, Medica superspecialty Hospital, Kolkata, WB, India Department of Approved 23/06/2017 No Orthopaedics, Jasleen Hospital, Opp. Big Bazar, Panchsheel Square, Dhantoli, Nagpur-440012, Maharashtra Nagpur MAHARASHTRA Ethics Committee, Approved 14/05/2017 No Ajanta Hospital and IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226005, Uttarpradesh, India. GMERS Medical Approved 11/07/2017 No College & Civil Hospital, Dept. of Orthopedics, Ground floor, Room No.
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5, Sola, Near Gujarat High Court, S. G. Highway, Ahmedabad 380061, Gujarat. IEC-YAMER, BH Approved 30/06/2017 No harihara kala bhavan, Secundarabad, Andhra Pradesh IEC-YAMER, BH Approved 30/06/2017 No harihara kala bhavan, Secundarabad, Andhra Pradesh IEC-YAMER, BH Approved 30/06/2017 No harihara kala bhavan, Secundarabad, Andhra Pradesh Institutional Ethics Approved 17/05/2017 No Committee for Human Research (IECHR), Dept. of Pharmacology, Medical College & SSG Hospital, Baroda-390001, Gujarat, India. Institutional Ethics Approved 21/05/2017 No Committee for M.V. Hospital & Research Centre, 1st Floor, 314/30, Mirza Mandi, Chowk, Lucknow-226003, Uttar Pradesh, India. Institutional Ethics Approved 14/06/2017 No Committee Grant Government Medical College & Sir J. J. Group of Hospitals, Byculla, Mumbai-400008, Maharashtra, India. Institutional Ethics Approved 20/06/2017 No Committee of B.J. Government Medical College & Sassoon General Hospitals, Dept. of Pharmacology, B J Medical College, Sassoon Road, Near Railway Station, Pune-411001, Maharashtra, India. Institutional Ethics Approved 21/06/2017 No Committee Sree Narayana Institute of Medical Science, ernakulam, Kerala Institutional Ethics Approved 03/08/2017 No Committee, B.J Medical college & civil Hospital,
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Office of the Medical Superintendent, Civil Hospital, Ahmedabad-380 016, Gujarat, India Institutional Ethics Approved 29/06/2017 No Committee, Dept. of Pharmacology, Govt. Medical College, Nagpur 440003, India. Institutional Ethics Approved 05/06/2017 No Committee, Govt Stanley Medical College & Hospital, Old Jail Road, Royapuram, Chennai - 600001, Tamil Nadu Institutional Ethics Approved 23/06/2017 No Committee, IMS and SUM Hospital, Bhubaneswar - 751003, Odisha, India Institutional Ethics Approved 24/06/2017 No committee, IPGMER, Bose road, Kolkata,India Institutional Ethics Approved 31/05/2017 No Committee, King George Hospital, Maharanipeta, Visakhapatnam-530002 , Andhrapradesh, India. Institutional Ethics Approved 24/07/2017 No Committee, King george university, Lucknow, Uttar pradesh Institutional Ethics Approved 12/05/2017 No Committee, Mysore Medical College and Research Institute, Mysore, Karnataka-570001 Institutional Ethics Approved 22/05/2017 No Committee, NKPSIMS and Lata Mangeshkar Institutional Ethics Approved 14/05/2017 No Committee, Om Surgical Center & Maternity Institutional Ethics Approved 16/05/2017 No Committee, Rathi Hospital, Nr. Anupam Shopping Centre, Opp. Mahabaleshwar Soc, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat.
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Institutional Ethics Approved 21/06/2017 No Committee- Human Research, Lokmanya Tilak Municipal Medical College Building, staff and research Society, Room No 17, 2nd Floor , Sion Mumbai- 400022 Medistar Hospital Approved 16/05/2017 No Ethics Committee (MHEC), Trimurti Avenue, Medistar Char Rasta, N.H.-8, Industrial Area, Himmatnagar-383001, Gujarat, India. Omega Ethical Approved 09/06/2017 No Committee, Omega Hospital, Mahaveer Circle, Kankanady, Mangalore - 575002, Karnataka, India. Parul University Approved 20/06/2017 No Institutional Ethics committee human Research, Waghodia, Vadodara Riddhi Medical Nursing Approved 17/05/2017 No Home Institutional Ethics Committee, A-101, Jalaram plaza, Near Jawahar chowk , Maninagar, Ahmedabad 380008, Gujarat, India. Sancheti Institutional Approved 02/06/2017 No Review Board, Sancheti Institute for Orthopedics & Rehabilitation, 16, Shivaji nagar, Pune, 411005, Maharashtra, India Sanjivani Hospital Approved 15/05/2017 No Ethics Committe, 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad-380015, Gujarat. Shree Giriraj Hospital Approved 03/06/2017 No Research Ethics Committee, Ground Floor, 150 Feet Ring Road, 27-Navjyot Park Main Road, Rajkot-36005, Gujarat, India. Supe Hospital Ethics Approved 22/05/2017 No Committee (SHEC), Supe Heart and
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Diabetes Hospital & Research Centre, Opp Adharashram, Gharpure Ghat, Near Rungta High School, Ashok Stambh, Nashik 422002, Maharashtra. Regulatory Clearance Status Date Status from DCGI Approved/Obtained 16/02/2017 Health Condition / Health Type Condition Problems Studied Patients Osteoarthritis (OA) of the Knee Intervention / Type Name Details Comparator Agent Comparator Agent Voltaren® Gel (Diclofenac Novartis Pharma Produktions Sodium Topical Gel) 1% GmbH. Dose: 4 gm Frequency: Four times a day Route of Administration: Topical Total Duration of Therapy: 4 weeks Intervention Diclofenac Sodium Gel, 1% Mylan Inc. Dose: 4 gm Frequency: Four times a day Route of Administration: Topical Total Duration of Therapy: 4 weeks Inclusion Criteria Inclusion Criteria Age From 35.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1. Healthy male or non-pregnant female aged ? 35 years with a clinical diagnosis of OA of the knee according to the American College of Rheumatology (ACR) criteria i.e. Knee pain along with at least 3 of the following 6 criteria
a. Age > 50 years
b. Stiffness < 30 minutes
c. Presence of crepitus
d. Bony tenderness
e. Bony enlargement
f. No palpable warmth
2. Symptoms in target knee for at least 6 months prior to screening
3. Knee (not referred) pain in target knee for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.)
4. Pain in the target knee requiring the use of NSAIDs or acetaminophen/paracetamol (topical or oral treatments).
5. Subject having 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.
6. After discontinuing all pain medications (placebo run – in period) for at least 7 days, had at least moderate pain on movement (POM) for target knee, defined as a baseline score of ? 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization
7. After discontinuing all pain medications (placebo run – in period) for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ?9 immediately prior to randomization.
8. Able to tolerate rescue medication with acetaminophen (paracetamol) taken as l-2 tablets up to a maximum 2 gm per day for the duration of the study.
9. Subjects who can read and understand WOMAC pain sub scale.
10. If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control:
a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of
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the study and remaining in place during the study period, or
b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or
c) Contraceptive Patches/ Implants, or
d) Abstinence: Subjects who will be practicing abstinence will agree to have a documented second acceptable method of birth control if the subject become sexually active during the course of her study participation.
Exclusion Criteria Exclusion Criteria Details 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 (placebo run-in period) for at least 7 days, had a baseline score of ? 20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization. 5. History of OA of either Hip or Hands 6. History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis. 7. History of chronic inflammatory disease (e.g., colitis) or fibromyalgia. 8. History of Drugs or Alcohol abuse within the previous year. 9. Symptomatic peripheral vascular disease of the study leg (prior or current). 10. Any musculoskeletal condition that would impede measurement of efficacy at the target knee. 11. History of regular headaches or backache which warrants often use of acetaminophen (paracetamol) within the previous year. 12. Concomitant skin disease at the application site which may affect study drug application or tolerability evaluation. 13. History of active asthma within the previous year that may require periodic treatment with systemic steroids during the study period (note: inhaled steroids for this condition are allowed). 14. History of aspirin sensitive asthma. 15. History of uncontrolled hypertension (blood pressure more than 150/100 mm of Hg) in spite of treatment within the previous year. 16. History of myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function (Serum creatinine > 1.5 x ULN) or liver disease within the previous year. 17. History of coronary artery bypass graft within 6 months of screening. 18. History of gastrointestinal bleeding or peptic ulcer disease in last one year. 19. Known allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol). 20. Elevated transaminases (? 3 times ULN) and Hemoglobin ? 9.0 g/dL at screening. 21. Viscosupplementation in any joint including the target knee within 6 months prior to screening 22. Receiving physical therapy (at an outpatient/clinic setting) for the lower extremities or having received physical therapy for the lower extremities within 1 month before screening. 23. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening. 24. Concomitant use of intra articular corticosteroids, systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening. 25. Concomitant acetylsalicylic acid therapy other than a stable low
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dose used for cardiac prophylaxis (maximum 162 mg daily) taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. 26. History of major surgery or previous damage to the study knee at any time, or minor knee surgery (e.g. any surgery other than major surgery including, but not limited to, cartilage repair, collateral ligament repair, or arthroscopic debridement) to the study knee within 1 year prior to screening. 27. Known history of positive HIV, HCV, or HBsAg. 28. Tense effusion requiring aspiration. 29. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to enrollment. 30. Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
Method of Generating Computer generated randomization Random Sequence Method of Other Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints • Mean change in the total WOMAC pain • Mean change in the total WOMAC pain subscale score for the target knee, from baseline subscale score for the target knee, from baseline to week 4 to week 4 Secondary Outcome Outcome Timepoints • Mean change in the total WOMAC pain 2 and 4 week subscale score for the target knee, from baseline to week 2. • Mean change in the WOMAC pain subscale score at week 4 for subgroup subjects whose baseline WOMAC pain score less than or equal to 10. Target Sample Size Total Sample Size=1212 Sample Size from India=1212 Final Enrollment numbers achieved (Total)=1220 Final Enrollment numbers achieved (India)=1220 Phase of Trial N/A Date of First 17/04/2017 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Nil Brief Summary Patients with Osteoarthritis (OA) of the Knee
Primary Objective
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1. To determine the clinical equivalence of Test Drug(Diclofenac sodium gel of 1% of Mylan Inc.) with the Reference Listed Drug (RLD)(Voltaren® Gel 1% of Novartis Consumer Health, Inc.) as measured by mean change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (version 3.1) pain score.
2. To establish superiority of the Test Drug and Reference Listed Drug (RLD) over placebo in mean change from baseline in the WOMAC Likert (version 3.1) pain score.
Secondary Objectives
1. To assess the safety and tolerability of study treatments.
2. To determine the clinical equivalence of Test Drug (Diclofenac Sodium gel) with the Reference Listed Drug (RLD)(Voltaren® Gel) as measured by mean change from baseline in subjects whose baseline WOMAC Likert (version 3.1) pain scores are less than or equal to 10.
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