Status:
COMPLETED
Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
1340 Patients enrolled
Trial Details
Trial ID
NCT00120900
Start Date
May 1 2005
End Date
September 1 2007
Last Update
January 19 2017
Active Locations (19)
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1
GSK Investigational Site
Ishøj, Denmark, 2635
2
GSK Investigational Site
De Bilt, Netherlands, 3731 DN
3
GSK Investigational Site
Ewijk, Netherlands, 6644 CL
4
GSK Investigational Site
Heerlen, Netherlands, 6416 EG