Efficacy of Dolasetron in Patients With Fibromyalgia (Dolastron)

University of Limoges (UL)

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Dolasetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00820326

I03002

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Dolasetron

Active Comparator group

Description:

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

Treatment:

Drug: Dolasetron

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo