Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
308 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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GW842166
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials, BSc MB PhD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hvidovre, , Denmark
GSK Investigational Site
Odense C, , Denmark
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Hamburg, City state of Hamburg, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, Germany
GSK Investigational Site
Leipzg, Saxony, Germany
GSK Investigational Site
Schmiedeberg, Saxony, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Centelles, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Petrer/Alicante, , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Gothenburg, , Sweden
GSK Investigational Site
Gothenburg, , Sweden
GSK Investigational Site
Helsingborg, , Sweden
GSK Investigational Site
Höllviken, , Sweden
GSK Investigational Site
Stocholm, , Sweden
GSK Investigational Site
Upplands Vasby, , Sweden
Countries
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Other Identifiers
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CBA109389
Identifier Type: -
Identifier Source: org_study_id
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