A Study of GW842166 in Adults With Osteoarthritis Pain - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00447486

Purpose

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

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: GW842166	Phase II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments [ Time Frame: 4 Weeks ]

Enrollment:	308
Study Start Date:	April 2007

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447486

Locations

Denmark
GSK Investigational Site
Hvidovre, Denmark, 2650
GSK Investigational Site
Odense C, Denmark, 5000
Germany
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 12051
GSK Investigational Site
Hamburg, Germany, 20249
Germany, Bayern
GSK Investigational Site
Muenchen, Bayern, Germany, 80333
Germany, Nordrhein-Westfalen
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Germany, Sachsen
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
Spain
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
Petrer/Alicante, Spain
GSK Investigational Site
Madrid, Spain, 28046
Sweden
GSK Investigational Site
UPPLANDS VÄSBY, Sweden, SE-194 89
GSK Investigational Site
GÖTEBORG, Sweden, SE-412 55
GSK Investigational Site
GÖTEBORG, Sweden, SE-416 85
GSK Investigational Site
HÖLLVIKEN, Sweden, SE-236 51
GSK Investigational Site
HELSINGBORG, Sweden, SE-252 78
GSK Investigational Site
STOCHOLM, Sweden, SE-17176

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, BSc MB PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CBA109389
Study First Received:	March 12, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00447486
Health Authority:	Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:

Osteoarthritis,
knee,
GW842166,

pain,
efficacy,
safety

Study placed in the following topic categories:

Osteoarthritis, Knee
Naproxen
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009