A Study of GW842166 in Adults With Osteoarthritis Pain

NCT ID: NCT00447486

Last Updated: 2009-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW842166

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, BSc MB PhD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hvidovre, , Denmark

Site Status

GSK Investigational Site

Odense C, , Denmark

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Leipzg, Saxony, Germany

Site Status

GSK Investigational Site

Schmiedeberg, Saxony, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

A Coruña, , Spain

Site Status

GSK Investigational Site

Centelles, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Petrer/Alicante, , Spain

Site Status

GSK Investigational Site

Santiago de Compostela, , Spain

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

GSK Investigational Site

Helsingborg, , Sweden

Site Status

GSK Investigational Site

Höllviken, , Sweden

Site Status

GSK Investigational Site

Stocholm, , Sweden

Site Status

GSK Investigational Site

Upplands Vasby, , Sweden

Site Status

Countries

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Denmark Germany Spain Sweden

Other Identifiers

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CBA109389

Identifier Type: -

Identifier Source: org_study_id

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