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

Study Overview
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Brief Summary
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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).

Official Title
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A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: valdecoxib
* Drug: naproxen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 10 mg tablet by mouth once daily for 6 weeks<br>|
| Active Comparator: Arm 2<br> | Drug: naproxen<br>* naproxen 500 mg capsule by mouth twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index |  | Week 2 and Week 6 | 
| WOMAC OA physical function |  | Week 2 and Week 6 | 
| WOMAC OA pain index |  | Week 2 and Week 6 | 
| 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 | 
| Physician's Global Assessment of Arthritis |  | Week 2 and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, osteoarthritis, hip