Efficacy of Dolasetron in Patients With Fibromyalgia

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Dolasetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.