NCT00532038

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.

An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)	Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-09-19
• Last updated: 2012-03-16

Locations

20 sites across 1 country: United States