A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.

Stopped early · Phase 3

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 the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.

Key facts

Study ID

NCT00532038

Run by

ZARS Pharma Inc.

People needed

179

Starts

2007-09-01

Expected to finish

2008-11-01

Last updated by the study team

2012-03-16

Who can join

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

You may qualify if…

• Patient completed a previous efficacy study of ThermoProfen.

You may not qualify if…

• Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
• Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
• Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
• Patient has a relevant history of serious gastrointestinal disease.
• Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
• Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
• Patient is taking warfarin, heparin, or low molecular weight heparin.
• Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.

Where it is running

• Study site — Anaheim, California, United States
• Study site — San Diego, California, United States
• Study site — Westlake Village, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Pembroke Pines, Florida, 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 — Kansas City, Missouri, United States
• Study site — Mercerville, New Jersey, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Anderson, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.