A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.

NCT00426621 Phase 3 COMPLETED

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Details

Lead sponsor	Novartis
Phase	Phase 3
Status	COMPLETED
Enrolment	420
Start date	2006-11
Completion	2007-06

Conditions

• Osteoarthritis of the Knee

Interventions

• Diclofenac Sodium Gel
• Placebo

Primary outcomes

• pain in the target knee (WOMAC pain index);
• functional capacity in the target knee (WOMAC function index); and
• global rating of benefit (100 mm Visual Analogue Scale, VAS).

Countries

United States