Fibromyalgia Syndrome, Primary
Conditions
Keywords
pain intensity, numerical rating scale, fibromyalgia
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.
Interventions
DRUGropinirole
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity score from baseline to last week of treatment (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Sweden, United Kingdom
Outcome results
None listed