Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen

Study Overview
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Brief Summary
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To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

Official Title
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A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: OA of the knee in flare state at baseline visit and functional capacity class of I-III Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability Exclusion criteria: Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) Received acetaminophen within 24 hours of baseline visit Use of mobility assisting device for less than six weeks prior to study screening or use of a walker History of gastrointestinal (GI) perforation, obstruction, or bleeding Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication Recieved 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 weeks<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Matched oral placebo for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index |  | Week 6 | 
| Patient's and Physician's Global Assessment of Pain |  | Weeks 2 and 6 | 
| The Medical Outcomes Study Sleep Scale |  | Week 6 | 
| Adverse events |  | Weeks 0-6 | 
| Laboratory tests |  | Week 6 | 
| Vital signs |  | Week 6 | 
| Physical examination |  | Week 6 | 
| Patient's Assessment of Arthritis Pain according to VAS |  | Week 2 | 
| Serious adverse events |  | Up to 30 days after last dose |