Fibromyalgia Study In Adults
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
1 other identifier
interventional
164
9 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedSeptember 15, 2016
September 1, 2016
November 21, 2005
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain intensity score from baseline to last week of treatment (week 12)
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Diepenbeek, 3590, Belgium
GSK Investigational Site
Merksem, 2170, Belgium
GSK Investigational Site
Frederiksberg, 2000, Denmark
GSK Investigational Site
Jyväskylä, 40100, Finland
GSK Investigational Site
Kuopio, 70100, Finland
GSK Investigational Site
Mikkeli, 50100, Finland
GSK Investigational Site
Lomme, 59160, France
GSK Investigational Site
Paris, 75006, France
GSK Investigational Site
Paris, 75012, France
GSK Investigational Site
Fellbach, Baden-Wurttemberg, 70736, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Bad Hersfeld, Hesse, 36251, Germany
GSK Investigational Site
Hüttenberg, Hesse, 35625, Germany
GSK Investigational Site
Benevento, Campania, 82100, Italy
GSK Investigational Site
Rome, Lazio, 00161, Italy
GSK Investigational Site
Milan, Lombardy, 20157, Italy
GSK Investigational Site
Zwolle, 8011 JW, Netherlands
GSK Investigational Site
Mölndal, SE-431 37, Sweden
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
GSK Investigational Site
Truro, Cornwall, TR1 3LJ, United Kingdom
GSK Investigational Site
Poole, Dorset, BH15 2JB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
November 1, 2004
Study Completion
July 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.