NCT00488267

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

A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 679 (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 ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

Detailed description

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)	Transdermal patch applied to the knee for 12 hours daily.
DRUG	Placebo Matrix/CHADD Patch	Transdermal patch applied to the knee for 12 hours daily.
DRUG	Ketoprofen matrix/placebo CHADD Patch	Transdermal knee applied to the knee for 12 hours daily.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2007-06-20
• Last updated: 2012-05-30

Locations

36 sites across 1 country: United States