A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Dolasetron
Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3
干预措施: Dolasetron (Drug)
Placebo
Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
干预措施: Placebo (Drug)
结局指标
主要结局
Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
时间窗: Inclusion visit and month 3
次要结局
- Anxiety index(Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.)
- 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.)
- Number of painful trigger points(Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.)