NCT00820326

Efficacy of Dolasetron in Patients With Fibromyalgia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Dolasetron	Patients will receive dolasetron at a dose of 12.5 mg / day 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

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2009-01-12
• Last updated: 2025-07-16

Locations

1 site across 1 country: France