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Fibromyalgia Study In Adults
This study has been completed.
First Received: November 21, 2005   Last Updated: October 15, 2008   History of Changes
Sponsored by: 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

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Ropinirole hydrochloride Ropinirole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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: November 2004
  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
Diepenbeek, Belgium, 3590
GSK Investigational Site
Merksem, Belgium, 2170
GSK Investigational Site
Bruxelles, Belgium, 1070
Denmark
GSK Investigational Site
Frederiksberg, Denmark, 2000
Finland
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Mikkeli, Finland, 50100
France
GSK Investigational Site
Paris, France, 75012
GSK Investigational Site
Paris, France, 75006
GSK Investigational Site
Lomme, France, 59160
Germany, Baden-Wuerttemberg
GSK Investigational Site
Fellbach, Baden-Wuerttemberg, Germany, 70736
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Germany, Hessen
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
GSK Investigational Site
Bad Hersfeld, Hessen, Germany, 36251
Italy, Campania
GSK Investigational Site
Benevento, Campania, Italy, 82100
Italy, Lazio
GSK Investigational Site
Roma, Lazio, Italy, 00161
Italy, Lombardia
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, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
United Kingdom, Cornwall
GSK Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
United Kingdom, Dorset
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: GSK ( Study Director )
Study ID Numbers: ROF102100
Study First Received: November 21, 2005
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00256893     History of Changes
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:
Neurotransmitter Agents
Ropinirole
Dopamine
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Dopamine Agents
Pain
Rheumatic Diseases
Dopamine Agonists

Additional relevant MeSH terms:
Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Fibromyalgia
Myofascial Pain Syndromes
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Rheumatic Diseases
Dopamine Agonists
Pharmacologic Actions
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009