NCT01456611

Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 749 (actual)
• Sponsor: Anchen Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteo Arthritis of the Knee

Interventions

Type	Name	Description
DRUG	Diclofenac	Diclofenac Sodium Gel 1%
DRUG	Placebo	Placebo Topical Gel

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-10-21
• Last updated: 2012-07-12

Locations

57 sites across 1 country: United States