A Study of GW842166 in Adults With Osteoarthritis Pain

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: GW842166

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447486

CBA109389

Details and patient eligibility

About

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

Enrollment: 308 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind