NCT00159731已完成4 期
An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.30 个研究点 分布在 1 个国家目标入组 160 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
- 160
- 试验地点
- 30
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Adverse events
次要结局
未报告次要终点
研究者
研究点 (30)
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