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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 30, 2005

Last Updated Date

October 13, 2008

Start Date ^†

May 2005

Current 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00120900 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Official Title ^†

See Detailed Description

Brief 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.

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).

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Osteoarthritis, Knee

Intervention ^†

Drug: GW406381

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1113

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Belgium, Canada, Denmark, Germany, Hungary, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Puerto Rico, Spain, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00120900

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.