To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).

Launched by GLENMARK PHARMACEUTICALS LTD. INDIA · Nov 3, 2015

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 2. OA Symptoms for at least 6 months prior to screening.
• • 3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of \> 9 on a 20 point scale for the target knee immediately prior to randomization.
• Exclusion Criteria:
• • 1. History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
• • 2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
• • 3. History of gastrointestinal bleeding or peptic ulcer disease.
• • 4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
• • 5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
• • 6. Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.