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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,340
GSK Investigational Site
Ishøj, Denmark
GSK Investigational Site
De Bilt, Netherlands
Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
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.
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GSK Investigational Site
Ewijk, Netherlands
GSK Investigational Site
Heerlen, Netherlands
GSK Investigational Site
Bergen, Norway
GSK Investigational Site
Hamar, Norway
GSK Investigational Site
Hønefoss, Norway
GSK Investigational Site
Lier, Norway
GSK Investigational Site
Oslo, Norway
GSK Investigational Site
Anyang-si, South Korea
...and 9 more locations