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...
Date First Received: June 30, 2005
Last Updated: September 18, 2006
Verified by: GlaxoSmithKline, September 2006
Clinical Trial Phase: Phase 3 | Start Date: May 2005
Overall Status: Completed
Estimated Enrollment: 1113
Brief Summary
Official Title: “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).”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
Secondary:
- 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.
Criteria for Participation in this Clinical Trial
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.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: GlaxoSmithKline
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Montgomery Alabama 36106 United States
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Huntsville Alabama 35801 United States
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Sun City Arizona 85351 United States
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Phoenix Arizona 85023 United States
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Scottsdale Arizona 85251 United States
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Little Rock Arkansas 72205 United States
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Jonesboro Arkansas 72401 United States
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Bentonville Arkansas 72712 United States
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Palm Desert California 92260 United States
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San Diego California 92128 United States
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Anaheim California 92801 United States
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Carmichael California 95608 United States
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Upland California 91786 United States
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Stratford Connecticut 06615 United States
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Washington District of Columbia 20006 United States
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Largo Florida 33773 United States
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Ocala Florida 34474 United States
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Rochester New York 14609 United States
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Oklahoma City Oklahoma 73112 United States
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Tulsa Oklahoma 74104 United States
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Oklahoma City Oklahoma 73112 United States
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Monroeville Pennsylvania 15146 United States
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Wynnewood Pennsylvania 19096 United States
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Duncansville Pennsylvania 16635 United States
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Mechanicsburg Pennsylvania 17055 United States
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Philadelphia Pennsylvania 19115 United States
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Charleston South Carolina 29406 United States
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Spartanburg South Carolina 29303 United States
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Mt. Pleasant South Carolina 29464 United States
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Murrells Inlet South Carolina 29576 United States
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Jackson Tennessee 38301 United States
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De Bilt 3731 DN Netherlands
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Christchurch 8001 New Zealand
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Otahuhu 1006 New Zealand
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Rotorua 3201 New Zealand
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Takapuna Auck. 1309 New Zealand
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Lima 27 Peru
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La Roca del Valles 08430 Spain
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Centelles Barcelona 08540 Spain
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Goteborg SE-416 85 Sweden
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Goteborg SE-400 10 Sweden
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Kungsbacka SE-434 35 Sweden
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Uppsala SE-753 21 Sweden
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Orebro SE-701 46 Sweden
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Helsingborg SE-252 78 Sweden
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Johanneshov SE-121 77 Sweden
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Stockholm SE-113 60 Sweden
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00120900
Study ID Number: CXA30007
ClinicalTrials.gov Identifier: NCT00120900
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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