Skip to main content
OpenTrials
Completed

NCT Number: NCT00120900

Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Ishøj, Denmark

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW406381

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 19, 2005
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.