Fibromyalgia Study In Adults
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia; Pain
Intervention: ropinirole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in pain intensity score from baseline to last week of treatment (week 12)
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Brussels 1070, Belgium
GSK Clinical Trials Call Center, Diepenbeek 3590, Belgium
GSK Clinical Trials Call Center, Merksem 2170, Belgium
GSK Clinical Trials Call Center, Frederiksberg 2000, Denmark
GSK Clinical Trials Call Center, Jyvaskyla 40100, Finland
GSK Clinical Trials Call Center, Kuopio 70100, Finland
GSK Clinical Trials Call Center, Mikkeli 50100, Finland
GSK Clinical Trials Call Center, Paris 75181, France
GSK Clinical Trials Call Center, Paris 75012, France
GSK Clinical Trials Call Center, Lomme 59160, France
GSK Clinical Trials Call Center, Bad Hersfeld 36251, Germany
GSK Clinical Trials Call Center, Fellbach 70736, Germany
GSK Clinical Trials Call Center, Huettenberg 35625, Germany
GSK Clinical Trials Call Center, Heidelberg 69120, Germany
GSK Clinical Trials Call Center, Roma 161, Italy
GSK Clinical Trials Call Center, Milano 20157, Italy
GSK Clinical Trials Call Center, Benevento 82100, Italy
GSK Clinical Trials Call Center, Zwolle 8011JW, Netherlands
GSK Clinical Trials Call Center, Molndal SE-43137, Sweden
GSK Clinical Trials Call Center, Poole BH15 2JB, United Kingdom
GSK Clinical Trials Call Center, Treliske TR1 3LJ, United Kingdom
GSK Clinical Trials Call Center, Cambridge CB2 2QQ, United Kingdom
Additional Information
Starting date: January 2005
Last updated: November 21, 2005
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