Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

A Phase III, 12-week, Multicentre, Double-Blind, Double-Dummy, Randomised, Placebo - and Active Comparator - Contolled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 XXmg and YYmg Administered Orally Once Daily, in Adults With Osteoarthritis of the Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120900

Enrollment

1340

Registered

2005-07-19

Start date

2005-05-31

Completion date

2007-09-30

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

COX-2 inhibitor, Knee osteoarthritis

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).

Interventions

DRUGGW406381

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Denmark, Netherlands, Norway, South Korea, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026