Efficacy of Dolasetron in Patients With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dolasetron

Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3

Group Type ACTIVE_COMPARATOR

Dolasetron

Intervention Type DRUG

Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3

Placebo

Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3

Interventions

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Dolasetron

Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3

Intervention Type DRUG

Placebo

Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No