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).
- Conditions
- Osteoarthritis
- Interventions
- Registration Number
- NCT02596451
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1164
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Voltaren® Gel Voltaren® Gel apply gel to the target knee Diclofenac Sodium gel, 1% Diclofenac Sodium gel, 1% apply gel to the target knee Placebo Placebo apply gel to the target knee
- Primary Outcome Measures
Name Time Method Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee Baseline and week 4 The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Glenmark Investigational Site 30
🇺🇸Carmichael, California, United States
Glenmark Investigational Site 34
🇺🇸Dallas, Texas, United States
Glenmark Investigational Site 31
🇺🇸Anaheim, California, United States
Glenmark Investigational Site 38
🇺🇸Wichita, Kansas, United States
Glenmark Investigational Site 19
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 28
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 39
🇺🇸Nashville, Tennessee, United States
Glenmark Investigational Site 29
🇺🇸San Antonio, Texas, United States
Glenmark Investigational Site 6
🇺🇸San Antonio, Texas, United States
Glenmark Investigational Site 40
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 11
🇺🇸West Palm Beach, Florida, United States
Glenmark Investigational Site 5
🇺🇸Mesa, Arizona, United States
Glenmark Investigational Site 3
🇺🇸Miami Lakes, Florida, United States
Glenmark Investigational Site 32
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 10
🇺🇸Fort Lauderdale, Florida, United States
Glenmark Investigational Site 37
🇺🇸Ormond Beach, Florida, United States
Glenmark Investigational Site 36
🇺🇸Knoxville, Tennessee, United States
Glenmark Investigational Site 22
🇺🇸Saginaw, Michigan, United States
Glenmark Investigational Site 21
🇺🇸Anaheim, California, United States
Glenmark Investigational Site 42
🇺🇸Carlsbad, California, United States
Glenmark Investigational Site 1
🇺🇸Anaheim, California, United States
Glenmark Investigational Site 26
🇺🇸Canoga Park, 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 15
🇺🇸Miami, Florida, United States
Glenmark Investigational Site 18
🇺🇸West Palm Beach, Florida, United States
Glenmark Investigational Site 43
🇺🇸Newburgh, Indiana, United States
Glenmark Investigational Site 9
🇺🇸Englewood, Ohio, United States
Glenmark Investigational Site7
🇺🇸Altoona, Pennsylvania, United States
Glenmark Investigational Site 14
🇺🇸Saint Louis, Missouri, United States
Glenmark Investigational Site 23
🇺🇸Beaumont, Texas, United States
Glenmark Investigational Site 20
🇺🇸Bryan, Texas, United States
Glenmark Investigational Site 4
🇺🇸Lampasas, Texas, United States
Glenmark Investigational Site 35
🇺🇸Houston, Texas, United States
Glenmark Investigational Site 44
🇺🇸Houston, Texas, United States
Glenmark Investigational Site 16
🇺🇸Charlottesville, Virginia, United States
Glenmark Investigational Site12
🇺🇸Midlothian, Virginia, United States
Glenmark Investigational Site 41
🇺🇸Hialeah, Florida, United States
Glenmark Investigational Site 8
🇺🇸Evanston, Illinois, United States
Glenmark Investigational Site 27
🇺🇸Sacramento, California, United States
Glenmark Investigational Site 17
🇺🇸New Orleans, Louisiana, United States