Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nuvo Research Inc.
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• Primary osteoarthritis of the knee, verified radiographically

• Moderate flare of pain in the knee after washout of stable therapy

• If female, non-pregnant

• Ability to swallow moderately-sized tablets

Exclusion Criteria:

• Secondary osteoarthritis of the knee

• Major knee surgery at any time, or minor knee surgery in previous year

• Severe uncontrolled heart, liver or kidney disease

• Ulcer or bleeding from the stomach

• Corticosteroid use

• Fibromyalgia

• Skin disorder of the knee