A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan
- Registration Number
- NCT00648258
- Lead Sponsor
- Pfizer
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2 of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing
- Knee OA diagnosis required diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing
- Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"
Exclusion Criteria
- Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 valdecoxib - Arm 2 naproxen -
- Primary Outcome Measures
Name Time Method Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) Week 6
- Secondary Outcome Measures
Name Time Method WOMAC OA stiffness index Week 2 and Week 6 Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) Week 2 Patient's Global Assessment of Arthritis Week 2 and Week 6 WOMAC OA physical function Week 2 and Week 6 WOMAC OA pain index Week 2 and Week 6 Physician's Global Assessment of Arthritis Week 2 and Week 6 Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index Week 2 and Week 6
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan