This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
265
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
Anyang, South Korea
Pfizer Investigational Site
Gwangju, South Korea
Pfizer Investigational Site
Incheon, South Korea
Pfizer Investigational Site
Pusan, South Korea
Pfizer Investigational Site
Seoul, South Korea
Pfizer Investigational Site
Seoul, South Korea
Pfizer Investigational Site
Seoul, South Korea
Pfizer Investigational Site
Seoul, South Korea
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 6
WOMAC OA Physical Function
Time frame: Week 2 and Week 6
WOMAC OA Stiffness Index
Time frame: Week 2 and Week 6
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 2
Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: Week 2 and Week 6
adverse events
Time frame: Continuous
Physician's Global Assessment of Arthritis Pain
Time frame: Week 2 and Week 6
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
Time frame: Week 2 and Week 6
WOMAC OA Pain Index
Time frame: Week 2 and Week 6
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