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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,164
Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee
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.
Time frame: Baseline and week 4
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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
...and 34 more locations