NCT00156078已完成4 期
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.35 个研究点 分布在 19 个国家目标入组 450 人开始时间: 2005年1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
- 450
- 试验地点
- 35
- 主要终点
- Mean pain score
研究概览
简要总结
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
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
- •Diagnosis of Type 1 or 2 diabetes mellitus.
- •Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
排除标准
- •Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- •Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
结局指标
主要结局
Mean pain score
次要结局
未报告次要终点
研究者
研究点 (35)
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