Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

Summary

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.

Timeline

Start

2011-09

Primary completion

2012-04

Completion

2012-04

Drugs

Indications