Status:
COMPLETED
A Study of GW842166 in Adults With Osteoarthritis Pain
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
Eligibility Criteria
Inclusion
- male or female outpatient, \>= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- meets ARA functional status requirements
- meets WOMAC pain subscale score requirements
- has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen
Exclusion
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
- history of peptic ulceration or GI bleeding
- use of protocol-specified medications
- secondary cause of knee OA
- lower extremity surgery within 6 months of screening
- use of analgesics other than allowed per protocol
- use of corticosteroids or hyaluronan outside of allowed window prior to screening
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00447486
Start Date
April 1 2007
Last Update
May 18 2009
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Hvidovre, Denmark, 2650
2
GSK Investigational Site
Odense C, Denmark, 5000
3
GSK Investigational Site
Munich, Bavaria, Germany, 80333
4
GSK Investigational Site
Hamburg, Hamburg, Germany, 20249