Official Title: “See Detailed Description”

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, Parallel Assignment, Safety/Efficacy Study

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).

Intervention(s) in this Clinical Trial

• Drug: GW406381

Primary Measures

• Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment

Secondary Measures

• 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.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

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