NCT00159705已完成3 期
A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.53 个研究点 分布在 8 个国家目标入组 276 人开始时间: 2005年4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
- 276
- 试验地点
- 53
- 主要终点
- Pain measurement
研究概览
简要总结
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
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
- •Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
- •Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.
排除标准
- •Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
- •Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
结局指标
主要结局
Pain measurement
次要结局
未报告次要终点
研究者
研究点 (53)
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