Skip to main content
OpenTrials
Completed

NCT Number: NCT00820326

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Rhumatologie, CHu de Limoges

Limoges, 87000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dolasetron

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Inclusion visit and month 3

Secondary outcomes

  1. Improving visual analogue scale (VAS)

    Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

  2. Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale

    Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

  3. Anxiety index

    Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

  4. Number of painful trigger points

    Time frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: Dolastron

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 12, 2009
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.