Status:
COMPLETED
Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT00643799
Start Date
March 1 2004
End Date
January 1 2005
Last Update
February 2 2021
Active Locations (51)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85014
3
Pfizer Investigational Site
Tempe, Arizona, United States, 85282
4
Pfizer Investigational Site
Buena Park, California, United States, 90620