NCT00447486

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for phase_2

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

First QC Date

March 12, 2007

Last Update Submit

May 15, 2009

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis,knee,GW842166,pain,efficacy,safety

Outcome Measures

Primary Outcomes (1)

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

    4 Weeks

Secondary Outcomes (1)

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

    4 Weeks

Interventions

GW842166DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

Odense C, 5000, Denmark

Location

GSK Investigational Site

Munich, Bavaria, 80333, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20249, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51069, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Leipzg, Saxony, 04109, Germany

Location

GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10559, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12051, Germany

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Centelles, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Petrer/Alicante, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Gothenburg, SE-412 55, Sweden

Location

GSK Investigational Site

Gothenburg, SE-416 85, Sweden

Location

GSK Investigational Site

Helsingborg, SE-252 78, Sweden

Location

GSK Investigational Site

Höllviken, SE-236 51, Sweden

Location

GSK Investigational Site

Stocholm, SE-17176, Sweden

Location

GSK Investigational Site

Upplands Vasby, SE-194 89, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials, BSc MB PhD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 14, 2007

Study Start

April 1, 2007

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

DE(9)SE(6)DK(2)ES(5)