Osteo Arthritis of the Knee Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee
The objective of this study is to evaluate the clinical equivalence and safety of the Test
formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to
the marketed formulation Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in
patients with osteoarthritis of the knee.
The efficacy of both the Test and Reference formulations will also be compared to the
Placebo gel to determine Superiority.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment