Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00120900

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: GW406381	Phase III

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome 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.

Estimated Enrollment:	1113
Study Start Date:	May 2005

Detailed 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).

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120900

Show 230 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CXA30007
Study First Received:	June 30, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00120900
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Knee osteoarthritis
COX-2 inhibitor

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009