Efficacy of Dolasetron in Patients With Fibromyalgia (Dolastron)

A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Dolasetron; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Service de Rhumatologie, CHu de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dolasetron; Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3	Drug: Dolasetron; Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
Placebo Comparator: Placebo; Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3	Drug: Placebo; Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
Anxiety index	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.

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Publications and helpful links

General Publications

• Vergne-Salle P, Dufauret-Lombard C, Bonnet C, Simon A, Treves R, Bonnabau H, Bertin P. A randomised, double-blind, placebo-controlled trial of dolasetron, a 5-hydroxytryptamine 3 receptor antagonist, in patients with fibromyalgia. Eur J Pain. 2011 May;15(5):509-14. doi: 10.1016/j.ejpain.2010.09.013. Epub 2010 Oct 30.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: December 27, 2008
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimated): January 12, 2009

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neurotransmitter Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Dolasetron
• Other Study ID Numbers: I03002