Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Phase 3

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT00120900
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-19
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Helsingborg, Sweden