To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
586
Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
Time frame: Month 6
Number of health care professional contacts
Time frame: Throughout study
Patient's and Physician's Satisfaction with Current Arthritis Therapy
Time frame: Month 6
Change in WOMAC Total Score from baseline
Time frame: Month 6
Change in WOMAC Subscales from baseline
Time frame: Month 6
Response in each WOMAC Subscale
Time frame: Month 6
Change in Medical Outcome Study sleep scale from baseline
Time frame: Month 6
Laboratory tests
Time frame: Month 6
Vital signs
Time frame: Month 6
Response in VAS
Time frame: Month 6
Change in Patient's and Physician's Global Assessment of Pain from baseline
Time frame: Month 6
Change in visual analog scale (VAS) from baseline
Time frame: Month 6
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Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tempe, Arizona, United States
Pfizer Investigational Site
Buena Park, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Rancho Mirage, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
...and 41 more locations
Adverse events
Time frame: Throughout study
Change in Gastrointestinal (GI) Distress Scale from Week 1
Time frame: Month 6
Change in GI Distress Scale from time of discontinuation of study drug
Time frame: Month 6
Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)
Time frame: Throughout study
Number of hospitalizations, emergency room visits, and procedures
Time frame: Throughout study
Change in Work Limitation Questionnaire scale scores from baseline
Time frame: Month 6
Physical examination
Time frame: Month 6