Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety
Brief summary
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
Interventions
DRUGGW842166
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline | 4 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments | 4 Weeks |
Countries
Denmark, Germany, Spain, Sweden
Outcome results
None listed