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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00488267

Run by

ZARS Pharma Inc.

People needed

679

Starts

2007-06-01

Expected to finish

2008-09-01

Last updated by the study team

2012-05-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 18 through 75 years of age
• Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.

You may not qualify if…

• 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.

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Buena Park, California, United States
• Study site — San Diego, California, United States
• Study site — Westlake Village, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — Milford, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Overland Park, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — Lansing, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Mercerville, New Jersey, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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