A Study of GW842166 in Adults With Osteoarthritis Pain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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