Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

NCT ID: NCT00120900

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-09-30

Brief Summary

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This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.

Detailed Description

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A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007).

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW406381

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
* Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.

Exclusion Criteria

* History of hypersensitivity or intolerance to pain medications.
* History of gastroduodenal perforations and/or obstructions.
* History of upper GI (gastrointestinal) ulceration within the previous 6 months.
* History of upper or lower GI bleeding within the previous year.
* History of inflammatory bowel disease.
* Currently take sucralfate or misoprostol.
* Currently taking aspirin daily for the heart.
* Other restrictions around the use medications apply and would need to be discussed.
* History of coronary artery disease, (angina, MI) or surgery.
* History of congestive heart failure or renal artery stenosis.
* History of stroke or transient ischemic attack.
* History of uncontrolled hypertension.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ishøj, , Denmark

Site Status

GSK Investigational Site

De Bilt, , Netherlands

Site Status

GSK Investigational Site

Ewijk, , Netherlands

Site Status

GSK Investigational Site

Heerlen, , Netherlands

Site Status

GSK Investigational Site

Bergen, , Norway

Site Status

GSK Investigational Site

Hamar, , Norway

Site Status

GSK Investigational Site

Hønefoss, , Norway

Site Status

GSK Investigational Site

Lier, , Norway

Site Status

GSK Investigational Site

Oslo, , Norway

Site Status

GSK Investigational Site

Anyang-si, , South Korea

Site Status

GSK Investigational Site

Daegu, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

San Juan, , Spain

Site Status

GSK Investigational Site

Helsingborg, , Sweden

Site Status

Countries

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Denmark Netherlands Norway South Korea Spain Sweden

Other Identifiers

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CXA30007

Identifier Type: -

Identifier Source: org_study_id

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