NCT00820326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
Last Updated

July 16, 2025

Status Verified

January 1, 2009

Enrollment Period

4.3 years

First QC Date

December 27, 2008

Last Update Submit

July 11, 2025

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3

    Inclusion visit and month 3

Secondary Outcomes (4)

  • 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.

Study Arms (2)

Dolasetron

ACTIVE COMPARATOR

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

Drug: Dolasetron

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DolasetronDRUG

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

Dolasetron
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie, CHu de Limoges

Limoges, 87000, France

Location

Related Publications (1)

  • 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.

    PMID: 21036635RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

dolasetron

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2008

First Posted

January 12, 2009

Study Start

March 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 16, 2025

Record last verified: 2009-01

Locations

FR(1)