Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Official Title
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A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Naproxen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit Functional Capacity Classification of I-III Exclusion Criteria: Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) Received acetaminophen within 24 hours of the baseline visit Acute joint trauma at index joint within the past 3 months with active symptoms History of gastrointestinal (GI) perforation, obstruction, or bleeding Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication Received corticosteroids or hyaluronic acid within certain timeframe before study

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Experimental: A<br> | Drug: Celecoxib<br>* 200 mg oral capsule once daily for 6 months<br>|
| Active Comparator: B<br> | Drug: Naproxen<br>* 500 mg oral capsule twice daily for 6 months<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* Matched oral placebo for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of health care professional contacts |  | Throughout study | 
| Patient's and Physician's Satisfaction with Current Arthritis Therapy |  | Month 6 | 
| Change in WOMAC Total Score from baseline |  | Month 6 | 
| Change in WOMAC Subscales from baseline |  | Month 6 | 
| Response in each WOMAC Subscale |  | Month 6 | 
| Change in Medical Outcome Study sleep scale from baseline |  | Month 6 | 
| Laboratory tests |  | Month 6 | 
| Vital signs |  | Month 6 | 
| Response in VAS |  | Month 6 | 
| Change in Patient's and Physician's Global Assessment of Pain from baseline |  | Month 6 | 
| Change in visual analog scale (VAS) from baseline |  | Month 6 | 
| Adverse events |  | Throughout study | 
| Change in Gastrointestinal (GI) Distress Scale from Week 1 |  | Month 6 | 
| Change in GI Distress Scale from time of discontinuation of study drug |  | Month 6 | 
| Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) |  | Throughout study | 
| Number of hospitalizations, emergency room visits, and procedures |  | Throughout study | 
| Change in Work Limitation Questionnaire scale scores from baseline |  | Month 6 | 
| Physical examination |  | Month 6 |