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.