Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.

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

Details

• Lead Sponsor: APR Applied Pharma Research s.a.; Endo Pharmaceuticals
• Treatments: Ketoprofen

Criteria

Inclusion Criteria:

• Males or females 18 years of age or older

• Diagnosis of osteoarthritis of the knee (unilateral or bilateral)

• Meet pain entry criteria

• Willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.

Exclusion Criteria:

• Positive urine pregnancy test, pregnant or lactating.

• Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease

• Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee

• Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit

• Have a history or physical examination finding that is incompatible with safe participation in the study or study product use

• Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.

• Have significant renal or hepatic impairment

• Are taking a sleep medication at a dose that has not been stable for at least 3 months