Fibromyalgia Study In Adults - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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:	November 2004

Intervention Details:

Other Name: ropinirole

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 Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Diepenbeek, Belgium, 3590
GSK Investigational Site
Merksem, Belgium, 2170
Denmark
GSK Investigational Site
Frederiksberg, Denmark, 2000
Finland
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Mikkeli, Finland, 50100
France
GSK Investigational Site
Lomme, France, 59160
GSK Investigational Site
Paris, France, 75012
GSK Investigational Site
Paris, France, 75006
Germany
GSK Investigational Site
Fellbach, Baden-Wuerttemberg, Germany, 70736
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Bad Hersfeld, Hessen, Germany, 36251
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
Italy
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Roma, Lazio, Italy, 00161
GSK Investigational Site
Milano, Lombardia, Italy, 20157
Netherlands
GSK Investigational Site
Zwolle, Netherlands, 8011 JW
Sweden
GSK Investigational Site
Mölndal, Sweden, SE-431 37
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
GSK Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
GSK Investigational Site
Poole, Dorset, United Kingdom, BH15 2JB

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00256893 History of Changes
Other Study ID Numbers:	ROF102100
Study First Received:	November 21, 2005
Last Updated:	June 4, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

fibromyalgia
pain intensity
numerical rating scale

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Ropinirole
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012