Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00120900
First received: June 30, 2005
Last updated: July 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: GW406381
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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.

Estimated Enrollment: 1113
Study Start Date: May 2005
Intervention Details:
    Drug: GW406381
    Other Name: GW406381
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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120900

Locations
Denmark
GSK Investigational Site
Ishoj, Denmark, 2635
Korea, Republic of
GSK Investigational Site
Anyang-Si, Korea, Republic of, 431-070
GSK Investigational Site
Daegu, Korea, Republic of, 705-718
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 133-792
Netherlands
GSK Investigational Site
De Bilt, Netherlands, 3731 DN
GSK Investigational Site
Ewijk, Netherlands, 6644 CL
GSK Investigational Site
Heerlen, Netherlands, 6416 EG
Norway
GSK Investigational Site
Bergen, Norway, N-5068
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Hønefoss, Norway, N-3515
GSK Investigational Site
Lier, Norway, 3400
GSK Investigational Site
Oslo, Norway, N-0370
Spain
GSK Investigational Site
San Juan, Spain
Sweden
GSK Investigational Site
Helsingborg, Sweden, SE-252 78
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00120900     History of Changes
Other Study ID Numbers: CXA30007
Study First Received: June 30, 2005
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
COX-2 inhibitor
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014