NCT00098124已完成3 期
A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Forest Laboratories81 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 81
- 主要终点
- Composite responder analysis based on pain and patient global status, with or without physical function.
研究概览
简要总结
Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.
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
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
- •Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
排除标准
- •Psychiatric illness
- •Depression
- •Suicidal risk
- •Substance abuse
- •Pulmonary dysfunction
- •Renal impairment
- •Active cardiac disease
- •Liver disease
- •Autoimmune disease
- •Sleep apnea
- •Inflammatory bowel disease
结局指标
主要结局
Composite responder analysis based on pain and patient global status, with or without physical function.
次要结局
- Quality of Life
- Health Assessment Questionnaire (HAQ) Disability Index
- Fatigue, sleep and cognitive assessments
研究者
研究点 (81)
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