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A Study of GW842166 in Adults With Osteoarthritis Pain

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00447486
First received: March 12, 2007
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Osteoarthritis, Knee
Drug: GW842166
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 308
Study Start Date: April 2007
Intervention Details:
    Drug: GW842166
    Other Name: GW842166
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447486

Locations
Denmark
GSK Investigational Site
Hvidovre, Denmark, 2650
GSK Investigational Site
Odense C, Denmark, 5000
Germany
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, 12051
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Hamburg, Germany, 20249
Spain
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
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-416 85
GSK Investigational Site
Göteborg, Sweden, SE-412 55
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, BSc MB PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00447486     History of Changes
Other Study ID Numbers: CBA109389
Study First Received: March 12, 2007
Last Updated: May 15, 2009
Health Authority: Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Osteoarthritis,
knee,
GW842166,
pain,
efficacy,
safety

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

ClinicalTrials.gov processed this record on November 25, 2014