NCT00348894终止2 期
A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
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
- 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 type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
- •Patients at screening must have a score >/=40 mm on the pain visual analogue scale
排除标准
- •Patients with significant hepatic impairment
- •Patients with other severe pain, that may impair the self-assessment of the pain due to DPN
研究组 & 干预措施
Open Treatment
Experimental
[S,S]-reboxetine
干预措施: [S,S]-Reboxetine (Drug)
Standard Care
Other
Standard Care
干预措施: Any (Drug)
结局指标
主要结局
Vital signs
时间窗: duration of study
Physical examination
时间窗: duration of study
12-lead ECG
时间窗: duration of study
Hematology/Biochemistry
时间窗: duration of study
Adverse events
时间窗: duration of study
次要结局
- Pain Visual Analogue Scale(duration of study)
- Neuropathic Pain Symptom Inventory(duration of study)
- Modified Brief Pain Inventory-Short Form(duration of study)
- Patient Global Impression of Change(duration of study)
- SF-12 Health Survey(duration of study)
- EQ-5D(duration of study)
- Analgesic Treatment Satisfaction Scale(duration of study)
- Pain-related Medication Utilization(duration of study)
研究者
研究点 (1)
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