NCT00230776已完成3 期
A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.90 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2005年10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
- 740
- 试验地点
- 90
- 主要终点
- To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
研究概览
简要总结
To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
- •Patients must have a score of >40 mm on the Visual Analog Scale
排除标准
- •Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
结局指标
主要结局
To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
次要结局
- To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.
研究者
研究点 (90)
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