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A Study of GW842166 in Adults With Osteoarthritis Pain

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW842166
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2007
Last Updated
May 15, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00447486
Brief Title
A Study of GW842166 in Adults With Osteoarthritis Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW842166
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, BSc MB PhD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
GSK Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzg
State/Province
Sachsen
ZIP/Postal Code
04109
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12051
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Centelles
Country
Spain
Facility Name
GSK Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Petrer/Alicante
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-412 55
Country
Sweden
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Helsingborg
ZIP/Postal Code
SE-252 78
Country
Sweden
Facility Name
GSK Investigational Site
City
Höllviken
ZIP/Postal Code
SE-236 51
Country
Sweden
Facility Name
GSK Investigational Site
City
Stocholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
GSK Investigational Site
City
Upplands Väsby
ZIP/Postal Code
SE-194 89
Country
Sweden

12. IPD Sharing Statement

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A Study of GW842166 in Adults With Osteoarthritis Pain

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