Official Title: “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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Diclofenac Sodium Gel
  • 4 grams per knee, 4 times per day, for 12 weeks
• Drug: Placebo
  • 4 grams per knee, 4 times per day, for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• 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).

Secondary Measures

• Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
• Low pain intensity in either knee; and
• Low functional impairment in either knee.
• Safety of Diclofenac Sodium Gel 1% assessed by:
• monitoring adverse events; and
• laboratory evaluations.

Inclusion Criteria:

• Osteoarthritis of the knee

Exclusion Criteria:

• Other rheumatic disease, such as rheumatoid arthritis
• Active gastrointestinal ulcer during the last year
• Known allergy to analgesic drugs
• Other protocol defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Roy Altman, MD Principal Investigator University of California, in Los Angeles, Division of Rheumatology, 310 206 7866  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426621

Study ID Number: VOSG-PN-316

ClinicalTrials.gov Identifier: NCT00426621

Health Authority: United States: Food and Drug Administration