Fibromyalgia Study In Adults

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

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-07-31

Brief Summary

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A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.

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Detailed Description

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Conditions

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Fibromyalgia Syndrome, Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ropinirole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary fibromyalgia as defined by the American College of Rheumatology (ACR).
* Females of childbearing potential will only be eligible if taking adequate contraceptive measures.
* Other co-existent chronic pain conditions such as osteoarthritis, will not exclude the subject if the pain associated with the condition is less severe than the pain of fibromyalgia.
* Only subjects experiencing moderate/severe pain (pain intensity score \>= 4 on the pain numerical rating scale) will be eligible for this study.
* Subjects that are generally well.
* Have the ability to discontinue prohibited medications for the duration of the study.

Exclusion Criteria

* Subjects with 'flare' of arthritic conditions.
* Evidence of clinically significant medical conditions including cardiovascular conditions (e.g. postural hypotension, and raised blood pressure, ECG abnormalities).
* History of drug and/or alcohol abuse or major depression.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Brussels, , Belgium

Site Status

GSK Investigational Site

Diepenbeek, , Belgium

Site Status

GSK Investigational Site

Merksem, , Belgium

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GSK Investigational Site

Frederiksberg, , Denmark

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GSK Investigational Site

Jyväskylä, , Finland

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GSK Investigational Site

Kuopio, , Finland

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GSK Investigational Site

Mikkeli, , Finland

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GSK Investigational Site

Lomme, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

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GSK Investigational Site

Fellbach, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

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GSK Investigational Site

Bad Hersfeld, Hesse, Germany

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GSK Investigational Site

Hüttenberg, Hesse, Germany

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GSK Investigational Site

Benevento, Campania, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Milan, Lombardy, Italy

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GSK Investigational Site

Zwolle, , Netherlands

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Mölndal, , Sweden

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GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

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GSK Investigational Site

Truro, Cornwall, United Kingdom

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GSK Investigational Site

Poole, Dorset, United Kingdom

Site Status

Countries

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Belgium Denmark Finland France Germany Italy Netherlands Sweden United Kingdom

Study Documents

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