NCT00597415

Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee

A Double-Blind, Placebo-Controlled, Randomized, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg QD in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis

Detailed description

We have developed a walking model that safely and reproducibly induces pain in subjects with knee OA in a manner that permits the comparison of the effect of different therapies on pain control. In a previous study, we demonstrated that a self-paced 20 minute walk followed by a one-hour rest and a second coordinator-paced 20-minute walk was well tolerated and generated moderate to severe pain in all participants within the time frame of the walk. We will now use this model, but with a crossover design to test the efficacy of celecoxib compared to placebo for the control of knee pain and improvement of walking function.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	celecoxib	celecoxib 200mg
DRUG	placebo	placebo

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2008-01-18
• Last updated: 2008-01-18

Locations

1 site across 1 country: United States