Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis
Phase 4
Completed
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT00643799
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 586
Inclusion Criteria
- Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
- Functional Capacity Classification of I-III
Exclusion Criteria
- Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of the baseline visit
- Acute joint trauma at index joint within the past 3 months with active symptoms
- History of gastrointestinal (GI) perforation, obstruction, or bleeding
- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
- Received corticosteroids or hyaluronic acid within certain timeframe before study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Placebo - B Naproxen - A Celecoxib -
- Primary Outcome Measures
Name Time Method Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score Month 6
- Secondary Outcome Measures
Name Time Method Number of health care professional contacts Throughout study Change in WOMAC Subscales from baseline Month 6 Response in VAS Month 6 Patient's and Physician's Satisfaction with Current Arthritis Therapy Month 6 Change in WOMAC Total Score from baseline Month 6 Change in Gastrointestinal (GI) Distress Scale from Week 1 Month 6 Change in Work Limitation Questionnaire scale scores from baseline Month 6 Response in each WOMAC Subscale Month 6 Vital signs Month 6 Number of hospitalizations, emergency room visits, and procedures Throughout study Change in Medical Outcome Study sleep scale from baseline Month 6 Change in Patient's and Physician's Global Assessment of Pain from baseline Month 6 Laboratory tests Month 6 Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) Throughout study Physical examination Month 6 Adverse events Throughout study Change in GI Distress Scale from time of discontinuation of study drug Month 6 Change in visual analog scale (VAS) from baseline Month 6
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Salt Lake City, Utah, United States
Pfizer Investigational Site🇺🇸Salt Lake City, Utah, United States