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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolasetron | Active Comparator | Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 |
|
| Placebo | Placebo Comparator | Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolasetron | Drug | Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3 | Inclusion visit and month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatologie, CHu de Limoges | Limoges | 87000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21036635 | Result | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C060344 | dolasetron |
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| Placebo | Drug | Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3 |
|
| 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. |
| D009422 |
| Nervous System Diseases |