Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: ropinirole
Enrollment:
164
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Fibromyalgia Syndrome, Primary
Product
ropinirole
Collaborators
Not applicable
Study date(s)
November 2004 to July 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Poole, Dorset, United Kingdom, BH15 2JB
Status
Study Complete
Location
GSK Investigational Site
Fellbach, Baden-Wuerttemberg, Germany, 70736
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-01-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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