NCT00508430终止2 期
ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 199
- 主要终点
- Pain severity rating
研究概览
简要总结
To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.
详细描述
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 20 - 79 years
- •Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
- •Subjects who are compliant with diary completion
排除标准
- •Subjects who have pain from other diseases at the evaluating site
- •Subjects who have nerve diseases at the evaluating site
- •Subjects with foot ulcer or gangrene
研究组 & 干预措施
1
Experimental
Low dose group
干预措施: ASP8825 (Drug)
2
Experimental
Middle dose group
干预措施: ASP8825 (Drug)
3
Experimental
High dose group
干预措施: ASP8825 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain severity rating
时间窗: 8 week
次要结局
- Responder rate(8 week)
- Severity of numbness, maximum pain, night pain and sleep disturbance.(8 week)
- Patient's global impression of change(8 week)
- Clinical's global impression of change(8 week)
研究者
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