NCT00125892已完成3 期
A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 31
- 主要终点
- Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome
研究概览
简要总结
This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists
排除标准
- •Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study.
- •Any patients judged by their physicians to be at serious suicidal risk.
- •Have uncontrolled narrow-angle glaucoma
结局指标
主要结局
Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome
次要结局
- Evaluate persistence of efficacy
- Evaluate long-term differences in efficacy in different doses
- Evaluate gains in efficacy in non-responders
研究者
研究点 (31)
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