A Study of GW842166 in Adults With Osteoarthritis Pain

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

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Hvidovre, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW842166

Drug

Primary outcomes

The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline

Time frame: 4 Weeks

Secondary outcomes

WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments

Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
First posted: Mar 14, 2007
Registry last updated: May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed