To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
naproxen 500 mg capsule by mouth twice daily for 6 weeks
Pfizer Investigational Site
Kweishan, Taoyuan, Taiwan
Pfizer Investigational Site
Kaohsiung City, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Time frame: Week 6
Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
Time frame: Week 2 and Week 6
WOMAC OA physical function
Time frame: Week 2 and Week 6
WOMAC OA pain index
Time frame: Week 2 and Week 6
WOMAC OA stiffness index
Time frame: Week 2 and Week 6
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Time frame: Week 2
Patient's Global Assessment of Arthritis
Time frame: Week 2 and Week 6
Physician's Global Assessment of Arthritis
Time frame: Week 2 and Week 6
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