Status:
COMPLETED
Fibromyalgia Study In Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Fibromyalgia Syndrome, Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00256893
Start Date
November 1 2004
End Date
July 1 2005
Last Update
September 15 2016
Active Locations (22)
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1
GSK Investigational Site
Brussels, Belgium, 1070
2
GSK Investigational Site
Diepenbeek, Belgium, 3590
3
GSK Investigational Site
Merksem, Belgium, 2170
4
GSK Investigational Site
Frederiksberg, Denmark, 2000