A Study of GW842166 in Adults With Osteoarthritis Pain
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00447486
First received: March 12, 2007
Last updated: May 15, 2009
Last verified: May 2009
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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
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, 10787 | |
| GSK Investigational Site | |
| Berlin, Germany, 10559 | |
| GSK Investigational Site | |
| Berlin, Germany, 12051 | |
| 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-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
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 May 21, 2013