NCT00357825已完成2 期
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 246
- 试验地点
- 62
- 主要终点
- Weekly Average Pain Score from the Daily Pain Diary.
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in 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
- •At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- •At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
排除标准
- •Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- •Patients with severe hepatic impairment.
结局指标
主要结局
Weekly Average Pain Score from the Daily Pain Diary.
次要结局
- Fibromyalgia Impact Questionnaire (FIQ) Total Score
- Patient Global Impression of Change
- Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
- Short-Form McGill Pain Questionnaire (SF-MPQ)
- Exposure Response Relationship Between Daily Dose and Daily Pain Score
- Short-Form 36 Health Survey (SF 36)
- Sheehan Disability Scale
- Quality of Sleep Score from the Daily Sleep Diary
- Multidimensional Assessment of Fatigue (MAF)
- Hospital Anxiety and Depression Scales (HADS)
- Safety and Tolerability
- Fibromyalgia Health Assessment Questionnaire (F-HAQ)
研究者
研究点 (62)
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