Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

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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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

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