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Sponsored by: |
GlaxoSmithKline |
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 |
MedlinePlus related topics: | Fibromyalgia |
ChemIDplus related topics: | Ropinirole Ropinirole hydrochloride |
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 |
Estimated Enrollment: | 164 |
Study Start Date: | January 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
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