A Study of GW842166 in Adults With Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447486
• Other study ID #: CBA109389
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2007
• Last updated: May 15, 2009
• Start date: April 2007

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• GW842166

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Odense C
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzg	Sachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Spain	GSK Investigational Site	Centelles
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Petrer/Alicante
Spain	GSK Investigational Site	Santiago de Compostela
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Höllviken
Sweden	GSK Investigational Site	Stocholm
Sweden	GSK Investigational Site	Upplands Väsby

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline		4 Weeks
Secondary	WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments		4 Weeks