Efficacy of Dolasetron in Patients With Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Placebo; Drug: Dolasetron

• Registration Number: NCT00820326
• Lead Sponsor: University Hospital, Limoges

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2008-06
• Study First Submitted: 2008-12-27
• Status Verified: 2009-01
• Study First Submitted QC: 2009-01-09
• Last Update Submitted: 2009-01-09
• Study First Posted: 2009-01-12
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
Dolasetron	Dolasetron	Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3

Primary Outcome Measures

Name	Time	Method
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3	Inclusion visit and month 3

Secondary Outcome Measures

Name	Time	Method
Anxiety index	Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Improving visual analogue scale (VAS)	Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale	Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Number of painful trigger points	Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

Trial Locations

Locations (1)

Service de Rhumatologie, CHu de Limoges; 🇫🇷 Limoges, France