NCT00108810

Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: ZARS Pharma Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Detailed description

Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

Conditions

• Pain
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Transdermal Ketoprofen Patch with CHADD	12 hours patch application for 28 days
DRUG	Placebo transdermal patch	12 hours application for 28 days

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-04-19
• Last updated: 2012-06-05

Locations

5 sites across 1 country: United States