Celebrex Total Knee Arthroplasty Study
- Registration Number
- NCT00359151
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- The subject is a male or female 18 years or older with osteoarthritis of the knee scheduled to undergo elective unilateral primary total knee arthroplasty because of OA, performed under a standardized regimen of anesthesia and procedure.
Exclusion Criteria
- Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis) other than osteoarthritis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celecoxib Celecoxib Celecoxib Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty. 19 July 2007
- Secondary Outcome Measures
Name Time Method To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase. 19 July 2007 To assess the safety and tolerability of celecoxib in this study population. 19 July 2007
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Houston, Texas, United States