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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
30
University Hospitals Case Medical Center
Beachwood, Ohio, United States
RECRUITINGThe primary endpoint is the time to onset of moderate and severe pain. The mean change in time to onset of moderate and sever pain between the first and second walks will be compared using paired t-tests.
Time frame: Visits 2 and 3
Secondary endpoints are the distance to onset of moderate to sever pain the the percent responders in each group. Thirty subjects will be studied in this randomized, placebo-controlled, double-blind crossover study.
Time frame: Visits 2 and 3
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