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Efficacy of Dolasetron in Patients With Fibromyalgia (Dolastron)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Dolasetron
Placebo
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Service de Rhumatologie, CHu de Limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dolasetron

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improving visual analogue scale (VAS)
Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale
Anxiety index
Number of painful trigger points

Full Information

First Posted
December 27, 2008
Last Updated
January 9, 2009
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00820326
Brief Title
Efficacy of Dolasetron in Patients With Fibromyalgia
Acronym
Dolastron
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dolasetron
Arm Type
Active Comparator
Arm Description
Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
Intervention Type
Drug
Intervention Name(s)
Dolasetron
Intervention Description
Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
Primary Outcome Measure Information:
Title
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
Time Frame
Inclusion visit and month 3
Secondary Outcome Measure Information:
Title
Improving visual analogue scale (VAS)
Time Frame
Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Title
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.
Title
Anxiety index
Time Frame
Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Title
Number of painful trigger points
Time Frame
Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Service de Rhumatologie, CHu de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France

12. IPD Sharing Statement

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Efficacy of Dolasetron in Patients With Fibromyalgia

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