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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: April 11, 2013
Last verified: November 2012
History of Changes

June 30, 2005
April 11, 2013
May 2005
Not Provided
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 at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment.
Complete list of historical versions of study NCT00120900 on ClinicalTrials.gov Archive Site
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.
  • Change in OA symptoms.
  • Percentage of responders.
  • Subjects discontinuing due to lack of efficacy.
  • Use of rescue medication.
  • Health-related quality of life.
Not Provided
Not Provided
 
Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee
See Detailed Description

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis, Knee
Drug: GW406381
Other Name: GW406381
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1113
Not Provided
Not Provided

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Korea, Republic of,   Netherlands,   Norway,   Spain,   Sweden
 
NCT00120900
CXA30007
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP