NCT00607256终止3 期
A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
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
研究组 & 干预措施
Open Label
Experimental
干预措施: [S,S]-reboxetine (Drug)
结局指标
主要结局
Adverse events
时间窗: 68 weeks
Vital signs
时间窗: 68 weeks
Physical examination
时间窗: 68 weeks
12-lead ECG
时间窗: 68 weeks
Hematology/Biochemistry
时间窗: 68 weeks
次要结局
- Patient Global Impression of Change(68 weeks)
研究者
研究点 (1)
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