Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Condition(s) targeted: Osteoarthritis

Intervention: Diclofenac Topical Sodium Gel 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

Official title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome:

WOMAC pain score in target knee at Week 12

WOMAC physical function score in target knee at Week 12

Global rating of disease activity by patient at Week 12

Secondary outcome:

WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8

WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12

Pain on movement in target knee and use of rescue medication recorded in diary

Global evaluation of treatment at final visit

Treatment responder rate according to OARSI criteria

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion criteria

- Osteoarthritis of the knee Key Exclusion criteria

- Other rheumatic disease, such as rheumatoid arthritis

- Active gastrointestinal ulcer during the last year

- Known allergy to analgesic drugs

Novartis Consumer Health Inc, Parsippany, New Jersey, United States

Last updated: May 29, 2006