Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

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

Details

• Lead Sponsor: ZARS Pharma Inc.
• Treatments: Ketoprofen

Criteria

Inclusion Criteria:

• Patient is 18 through 75 years of age

• Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.

Exclusion Criteria:

• Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).

• Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.

• Patient has a relevant history of serious gastrointestinal disease.

• Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.

• Patient is taking warfarin, heparin, or low molecular weight heparin.

• Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).

• Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.