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.

Phase 3

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT00532038
• Lead Sponsor: ZARS Pharma Inc.

Brief 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 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.

Detailed Description

The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Patient completed a previous efficacy study of ThermoProfen.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of long-term administration of ThermoProfen™	up to 12 months