A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
NCT ID: NCT03172780
Last Updated: 2022-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1220 participants
INTERVENTIONAL
2017-05-24
2017-12-05
Brief Summary
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Male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the American College of Rheumatology (ACR) criteria
Total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Diclofenac Sodium Gel
Diclofenac Sodium Gel, 1%
Diclofenac sodium gel 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren® Gel
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Placebo gel
Placebo gel
Placebo gel
Vehicle Gel 4 gm, 4 times a day for 4 weeks
Interventions
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Diclofenac sodium gel 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Placebo gel
Vehicle Gel 4 gm, 4 times a day for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
* After discontinuing all pain medications 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.
* Able to tolerate rescue medication with acetaminophen
* Subjects who can read and understand WOMAC pain sub scale
Exclusion Criteria
* OA of Kellgren-Lawrence grade 4
* OA pain in the contralateral knee requiring medication (OTC or prescription)
* History of OA of either Hip or Hands
* History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
* History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
* History of Drugs or Alcohol abuse within the previous year
* Symptomatic peripheral vascular disease of the study leg
* Any musculoskeletal condition
* Skin disease at the application site
* Active asthma requiring periodic treatment with systemic steroids
* Known history of positive HIV, hepatitis C virus, or HBsAg
* Uncontrolled hypertension
* History of myocardial infarction, thrombotic events, stroke etc.
* Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
35 Years
ALL
No
Sponsors
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Mylan Pharmaceuticals Private Limited
INDUSTRY
Responsible Party
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Locations
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Yashoda Hospital - Malakpet
Hyderabad, Andhra Pradesh, India
Yashoda Hospital -Secunderabad
Secunderabad, Andhra Pradesh, India
Yashoda Hospital -Somajiguda
Somajiguda, Andhra Pradesh, India
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Riddhi Medical Nursing Home
Ahmedabad, Gujarat, India
Rathi Hospital
Ahmedabad, Gujarat, India
Sanjivani Superspeciality Hospital Pvt. Ltd
Ahmedabad, Gujarat, India
B.J Medical College & Civil Hospital
Ahmedabad, Gujarat, India
GMERS Medical College & Civil Hospital
Ahmedabad, Gujarat, India
Medistar Multispeciality Hospital
Himmatnagar, Gujarat, India
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
SSG Hospital and Medical College
Vadodara, Gujarat, India
Anand Multispeciality Hospital
Vadodara, Gujarat, India
Parul Sevashram Hospital
Vadodara, Gujarat, India
Omega Hospital
Mangalore, Karnataka, India
Mysore Medical College and Research Institute
Mysore, Karnataka, India
Sree Narayana Institute of Medical Science
Ernākulam, Kerala, India
Sir J. J. Group of Hospital and Grant Government Hospital
Mumbai, Maharashtra, India
Lokmanya Tilak Municipal Medical College & General Hospital
Mumbai, Maharashtra, India
Government Medical College and Hospital
Nagpur, Maharashtra, India
Jasleen Hospital
Nagpur, Maharashtra, India
Institute of Medical sciences and Lata Mangeshkar
Nagpur, Maharashtra, India
Supe Heart and Diabetes Hospital & Research Centre
Nashik, Maharashtra, India
BJ medical college & Sassoon General Hospital
Pune, Maharashtra, India
Sancheti Institute for Orthopedics & Rehabilitation
Pune, Maharashtra, India
BhaktiVedanta Hospital and Research Institute
Thāne, Maharashtra, India
IMS and SUM Hospital
Bhubaneshwar, Odisha, India
Govt Stanley Medical College & Hospital
Chennai, Tamil Nadu, India
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, India
Ajanta Research Centre
Lucknow, Uttar Pradesh, India
OM surgical Centre and Maternity Home
Varanasi, Uttar Pradesh, India
Institute of Post Graduate Medical Education and Research (IPGMER), Department of Orthopaedics
Kolkata, West Bengal, India
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MYL-1601N-3002
Identifier Type: -
Identifier Source: org_study_id
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