A Study of GW842166 in Adults With Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447486
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : May 18, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: GW842166 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments [ Time Frame: 4 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447486

GSK Investigational Site
Hvidovre, Denmark, 2650
GSK Investigational Site
Odense C, Denmark, 5000
GSK Investigational Site
Muenchen, Bayern, Germany, 80333
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 12051
GSK Investigational Site
Hamburg, Germany, 20249
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Petrer/Alicante, Spain
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Göteborg, Sweden, SE-412 55
GSK Investigational Site
Göteborg, Sweden, SE-416 85
GSK Investigational Site
Helsingborg, Sweden, SE-252 78
GSK Investigational Site
Höllviken, Sweden, SE-236 51
GSK Investigational Site
Stocholm, Sweden, SE-17176
GSK Investigational Site
Upplands Väsby, Sweden, SE-194 89
Sponsors and Collaborators
Study Director: GSK Clinical Trials, BSc MB PhD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00447486     History of Changes
Other Study ID Numbers: CBA109389
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases