NCT00159679已完成4 期
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.31 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 31
- 主要终点
- Nerve conduction measurements; Pain scores from patient diaries
研究概览
简要总结
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.
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
- Double
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
- •Adults with Type 1 or 2 diabetes
- •Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months
排除标准
- •Patients must not be in poor or unstable health.
结局指标
主要结局
Nerve conduction measurements; Pain scores from patient diaries
次要结局
- Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change
研究者
研究点 (31)
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