Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Study Overview
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Brief Summary
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This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.

Detailed Description
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A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007).

Official Title
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A Phase III, 12-week, Multicentre, Double-Blind, Double-Dummy, Randomised, Placebo - and Active Comparator - Contolled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 XXmg and YYmg Administered Orally Once Daily, in Adults With Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: GW406381


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months. Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week. Exclusion criteria: History of hypersensitivity or intolerance to pain medications. History of gastroduodenal perforations and/or obstructions. History of upper GI (gastrointestinal) ulceration within the previous 6 months. History of upper or lower GI bleeding within the previous year. History of inflammatory bowel disease. Currently take sucralfate or misoprostol. Currently taking aspirin daily for the heart. Other restrictions around the use medications apply and would need to be discussed. History of coronary artery disease, (angina, MI) or surgery. History of congestive heart failure or renal artery stenosis. History of stroke or transient ischemic attack. History of uncontrolled hypertension.

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

| Intervention/Treatment |
| --- |
|Drug: GW406381|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OA symptoms as measured by subject and physician-completed questionnaires at each scheduled visit. Percentage of responders, subjects discontinuing due to lack of efficacy, use of rescue medication and health-related quality of life. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COX-2 inhibitor, Knee osteoarthritis