Fibromyalgia Study In Adults - Full Text View

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia Pain	Drug: ropinirole	Phase II

MedlinePlus related topics:

Fibromyalgia

ChemIDplus related topics:

Ropinirole Ropinirole hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Randomised, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-Release Ropinirole (CR) (1-24 Mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in pain intensity score from baseline to last week of treatment (week 12)

Secondary Outcome Measures:

Pain relief. Global function: PGIC (Patient Global Impression of Change)and CGIC (Clinical Global Impression of Change), FIQ (Fibromyalgia Impact Questionnaire), Pain severity and impact on physical function, Sleep quality, tender pointpressure threshold

Estimated Enrollment:	164
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256893

Locations


Belgium
	GSK Clinical Trials Call Center
	Brussels, Belgium, 1070
	GSK Clinical Trials Call Center
	Diepenbeek, Belgium, 3590
	GSK Clinical Trials Call Center
	Merksem, Belgium, 2170

Denmark
	GSK Clinical Trials Call Center
	Frederiksberg, Denmark, 2000

Finland
	GSK Clinical Trials Call Center
	Jyvaskyla, Finland, 40100
	GSK Clinical Trials Call Center
	Kuopio, Finland, 70100
	GSK Clinical Trials Call Center
	Mikkeli, Finland, 50100

France
	GSK Clinical Trials Call Center
	Paris, France, 75181
	GSK Clinical Trials Call Center
	Paris, France, 75012
	GSK Clinical Trials Call Center
	Lomme, France, 59160

Germany
	GSK Clinical Trials Call Center
	Bad Hersfeld, Germany, 36251
	GSK Clinical Trials Call Center
	Fellbach, Germany, 70736
	GSK Clinical Trials Call Center
	Huettenberg, Germany, 35625
	GSK Clinical Trials Call Center
	Heidelberg, Germany, 69120

Italy
	GSK Clinical Trials Call Center
	Roma, Italy, 161
	GSK Clinical Trials Call Center
	Milano, Italy, 20157
	GSK Clinical Trials Call Center
	Benevento, Italy, 82100

Netherlands
	GSK Clinical Trials Call Center
	Zwolle, Netherlands, 8011JW

Sweden
	GSK Clinical Trials Call Center
	Molndal, Sweden, SE-43137

United Kingdom
	GSK Clinical Trials Call Center
	Poole, United Kingdom, BH15 2JB
	GSK Clinical Trials Call Center
	Treliske, United Kingdom, TR1 3LJ
	GSK Clinical Trials Call Center
	Cambridge, United Kingdom, CB2 2QQ

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	ROF102100
First Received:	November 21, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00256893
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

fibromyalgia

pain intensity

numerical rating scale

Study placed in the following topic categories:

Ropinirole

Dopamine

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Pain

Rheumatic Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Antiparkinson Agents

Dopamine Agents

Dopamine Agonists

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00256893