NCT00722852

Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: IDEA AG · Industry
• Sex: All
• Age: 46 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Detailed description

The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	ketoprofen in Diractin®	100 mg (b.i.d.)
DRUG	Placebo	100 mg (b.i.d.)

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-02-01
• Completion: 2009-04-01
• First posted: 2008-07-28
• Last updated: 2009-10-05

Locations

37 sites across 1 country: United States