NCT00004647已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
National Center for Research Resources (NCRR)0 个研究点目标入组 40 人开始时间: 1993年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
OBJECTIVES:
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
详细描述
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.
The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful diabetic neuropathy
排除标准
- 未提供
研究者
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