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 Voltaren in the treatment of knee osteoarthritis.

Official title: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome:

Incidence of treatment-emergent adverse events

Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary outcome:

Incidence of serious treatment-emergent adverse events

Number of patients who discontinued study medication due to a treatment-emergent adverse event

WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

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