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).
Completed · Phase 3 · Has a placebo group
Conditions studied: Osteoarthritis
In brief
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
Key facts
- Study ID
- NCT02596451
- Run by
- Glenmark Pharmaceuticals Ltd. India
- People needed
- 1164
- Starts
- 2015-08-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-06-28
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- OA Symptoms for at least 6 months prior to screening.
- Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20 point scale for the target knee immediately prior to randomization.
You may not qualify if…
- History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
- History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).
- Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening.
- Concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
Where it is running
- Glenmark Investigational Site 5 — Mesa, Arizona, United States
- Glenmark Investigational Site 1 — Anaheim, California, United States
- Glenmark Investigational Site 21 — Anaheim, California, United States
- Glenmark Investigational Site 31 — Anaheim, California, United States
- Glenmark Investigational Site 26 — Canoga Park, California, United States
- Glenmark Investigational Site 42 — Carlsbad, California, United States
- Glenmark Investigational Site 30 — Carmichael, California, United States
- Glenmark Investigational Site 33 — Cerritos, California, United States
- Glenmark Investigational Site 25 — El Cajon, California, United States
- Glenmark Investigational Site 24 — La Mesa, California, United States
- Glenmark Investigational Site 2 — Pasadena, California, United States
- Glenmark Investigational Site 13 — Rancho Cucamonga, California, United States
- Glenmark Investigational Site 27 — Sacramento, California, United States
- Glenmark Investigational Site 10 — Fort Lauderdale, Florida, United States
- Glenmark Investigational Site 41 — Hialeah, Florida, United States
- Glenmark Investigational Site 15 — Miami, Florida, United States
- Glenmark Investigational Site 19 — Miami, Florida, United States
- Glenmark Investigational Site 28 — Miami, Florida, United States
- Glenmark Investigational Site 32 — Miami, Florida, United States
- Glenmark Investigational Site 40 — Miami, Florida, United States
- Glenmark Investigational Site 3 — Miami Lakes, Florida, United States
- Glenmark Investigational Site 37 — Ormond Beach, Florida, United States
- Glenmark Investigational Site 11 — West Palm Beach, Florida, United States
- Glenmark Investigational Site 18 — West Palm Beach, Florida, United States
- Glenmark Investigational Site 8 — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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