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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00256893 |
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: | 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 |
Estimated Enrollment: | 164 |
Study Start Date: | November 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
fibromyalgia pain intensity numerical rating scale |
Neurotransmitter Agents Ropinirole Dopamine Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myofascial Pain Syndromes Fibromyalgia Dopamine Agents Pain Rheumatic Diseases Dopamine Agonists |
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 |