NCT00143156已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.55 个研究点 分布在 2 个国家目标入组 450 人开始时间: 2005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
- 450
- 试验地点
- 55
- 主要终点
- The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
研究概览
简要总结
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
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
- •Males or females at least 18 years of age, of any ethnic origin
- •Type 1 or 2 diabetes mellitus
- •Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
排除标准
- •Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- •Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
结局指标
主要结局
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
次要结局
- End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.
研究者
研究点 (55)
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