To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
388
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
Time frame: Week 6
Patient's Assessment of Arthritis Pain, according to VAS
Time frame: Week 2
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 6
Patient's and Physician's Global Assessment of Arthritis
Time frame: Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Time frame: Week 6
Adverse events
Time frame: Weeks 0-6
Laboratory tests
Time frame: Week 6
Vital signs
Time frame: Week 6
Physical examination
Time frame: Week 6
Serious adverse events
Time frame: Up to 30 days after last dose
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Buena Park, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Longwood, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Zephyrhills, Florida, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Morton Grove, Illinois, United States
...and 23 more locations