Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.