Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis, Knee

Treatments

Drug: GW406381

Study type

Interventional

Funder types

Industry

Identifiers

NCT00120900

CXA30007

Details and patient eligibility

About

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.

Full description

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).

Enrollment

1,340 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.