Efficacy of Dolasetron in Patients With Fibromyalgia (Dolastron)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00820326
First received: December 27, 2008
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Dolasetron
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3 [ Time Frame: Inclusion visit and month 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improving visual analogue scale (VAS) [ Time Frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Anxiety index [ Time Frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. ] [ Designated as safety issue: Yes ]
  • Number of painful trigger points [ Time Frame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2004
Study Completion Date: June 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820326

Locations
France
Service de Rhumatologie, CHu de Limoges
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: Marie SENGELEN, CHU de Limoges
ClinicalTrials.gov Identifier: NCT00820326     History of Changes
Other Study ID Numbers: I03002
Study First Received: December 27, 2008
Last Updated: January 9, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Dolasetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014