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
Overview
- Phase
- Phase 3
- Intervention
- Voltaren® Gel
- Conditions
- Osteoarthritis
- Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Enrollment
- 1164
- Locations
- 44
- Primary Endpoint
- Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Voltaren® Gel
apply gel to the target knee
Intervention: Voltaren® Gel
Diclofenac Sodium gel, 1%
apply gel to the target knee
Intervention: Diclofenac Sodium gel, 1%
Placebo
apply gel to the target knee
Intervention: Placebo
Outcomes
Primary Outcomes
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
Time Frame: 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.