NCT00436033已完成3 期
A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,429
- 试验地点
- 13
- 主要终点
- To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion
研究概览
简要总结
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria
排除标准
- •psychiatric illness
- •depression of generalised anxiety disorder
- •suicidal risk
- •substance abuse
- •active cardiac disease
- •pulmonary dysfunction
- •liver disease
- •renal impairment
- •autoimmune disease
- •chronic inflammatory rheumatoid disease
- •current systemic infection
- •epileptic
- •active cancer
- •sleep apnea
- •active peptic ulcer
- •inflammatory bowel disease
- •unstable endocrine disease
- •for men : prostatic enlargement of genito-urinary disorders
- •for women : pregnancy or breast feeding
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Minalcipran
Experimental
干预措施: milnacipran (Drug)
结局指标
主要结局
To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion
时间窗: 12 weeks
次要结局
- comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria(12 weeks)
- establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).(19 weeks)
研究者
研究点 (13)
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