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Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00120900
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: GW406381 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : May 2005
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 133-792
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of
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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00120900     History of Changes
Other Study ID Numbers: CXA30007
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Keywords provided by GlaxoSmithKline:
COX-2 inhibitor
Knee osteoarthritis

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