NCT02460107终止早期 1 期
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Catholic University of Korea Saint Paul's Hospital1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pain intensity using numeric rating scale
研究概览
简要总结
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• more than twenty years of age
- •patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.
- •persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
- •a pain score of 4 or more on the numeric rating scale
排除标准
- •• neuropathic pain caused by confounding factors other than diabetic neuropathic pain
- •contraindicated for botulinum toxin type A
- •a change in pain medication one month prior to study enrollment
- •a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
- •person who received botulinum toxin type A within three months prior to study enrollment
研究组 & 干预措施
Normal saline
Placebo Comparator
Normal saline
干预措施: Normal saline (Other)
Botulinum toxin type A 50U
Active Comparator
Botulinum toxin 50U
干预措施: Botulinum toxin type A (Biological)
Botulinum toxin type A 100U
Active Comparator
Botulinum toxin 100U
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
Pain intensity using numeric rating scale
时间窗: 4 weeks after intervention
次要结局
- Pain intensity using numeric rating scale(1, 8, 12, 24 weeks after intervention)
- Quality of life using WHOQOL(4,8,12 weeks after intervention)
研究者
Myung Eun Chung, MD, PhD
Catholic University of Korea Saint Paul's Hospital
Catholic University of Korea Saint Paul's Hospital
研究点 (1)
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