Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: valdecoxib
* Drug: naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria) Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit Exclusion Criteria: Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee Symptomatic anserine bursitis or acute joint trauma of the Index Knee Arthroscopy performed on the Index Knee within the past 12 months Complete loss of articular cartilage of the Index Knee Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively

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: Triple


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 using a Visual Analogue Scale (OA-Pain VAS) |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC OA Physical Function |  | Week 2 and Week 6 | 
| WOMAC OA Stiffness Index |  | Week 2 and Week 6 | 
| Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) |  | Week 2 | 
| Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) |  | Week 2 and Week 6 | 
| adverse events |  | Continuous | 
| Physician's Global Assessment of Arthritis Pain |  | Week 2 and Week 6 | 
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index |  | Week 2 and Week 6 | 
| WOMAC OA Pain Index |  | Week 2 and Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, OA patients