Status:
COMPLETED
Efficacy of Dolasetron in Patients With Fibromyalgia
Lead Sponsor:
University Hospital, Limoges
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization. This study is double blind (neither you nor the p...
Eligibility Criteria
Inclusion
- Patients aged 18 to 75
- Primitive Fibromyalgia according to ACR criteria
- Patient no responding to conventional treatment
- Women of childbearing age using an efficace contraception
- Signed consent
Exclusion
- Inflammatory rheumatic diseases
- Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
- Infectious diseases: hepatitis B and C, lyme disease, HIV,
- Hypothyroidism,
- Bone and mineral metabolism disorders
- Disorders of cardiac conduction
- Failure of Heart, of kidney or liver,
- Patient allergic to dolasetron
- Pregnant or nursing women
- Women without means of contraception,
- Age \<18 or \> 75 years.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00820326
Start Date
March 1 2004
End Date
June 1 2008
Last Update
July 16 2025
Active Locations (1)
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1
Service de Rhumatologie, CHu de Limoges
Limoges, France, 87000