A Study of GW842166 in Adults With Osteoarthritis Pain

A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee

The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.

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