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

The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.

The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

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.