NCT00757731已完成3 期
A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the 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
- 490
- 试验地点
- 10
- 主要终点
- To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
研究概览
简要总结
Investigation of the long-term (12 months) efficacy and safety of milnacipran used 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 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who completed the 3-month F02207 GE 302 study
- •patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study
排除标准
- •known hypersensitivity to milnacipran
- •major depressive episode
- •significant risk of suicide
- •generalised anxiety disorder
- •substance abuse
- •clinically significant cardiac disease
- •pulmonary dysfunction
- •active liver disease
- •renal impairment
- •autoimmune disease
- •current systemic infection
- •epileptic
- •active cancer
- •severe sleep apnoea
- •active peptic ulcer
- •inflammatory bowel disease
- •unstable endocrine disease
- •(for men) prostatic enlargement or other genito-urinary disorders
- •(for women) pregnancy or breastfeeding
研究组 & 干预措施
Minalcipran 100 mg
Experimental
干预措施: milnacipran (Drug)
Minalcipran 100 mg
Experimental
干预措施: Placebo (Drug)
Minalcipran 150 mg
Experimental
干预措施: milnacipran (Drug)
Minalcipran 150 mg
Experimental
干预措施: Placebo (Drug)
Minalcipran 200 mg
Experimental
干预措施: milnacipran (Drug)
Minalcipran 200 mg
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily
时间窗: 12 months
次要结局
- To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily(12 months)
研究者
研究点 (10)
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