A Study of GW842166 in Adults With Osteoarthritis Pain
Phase 2
Completed
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT00447486
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline 4 Weeks
- Secondary Outcome Measures
Name Time Method WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments 4 Weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇸🇪Upplands Väsby, Sweden