ACTRN12609000207213已完成2 期
A randomised, double-blind, placebo-controlled, phase 2a trial of ENBREL (Etanercept) administered by the transforaminal epidural route for the treatment of lumbosacral radiculopathy. (BDCISP2ENBREL)
Bioassets Development Corporation0 个研究点目标入组 40 人开始时间: 2009年4月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Healthy males or females with primary diagnosis of sciatica (lumbosacral radiculopathy) of between 6 and 26 weeks duration. Must have negative tuberculin skin test. Sciatica must been confirmed by Magnetic Resonance Imaging (MRI), have positive straight leg raise at screening or positive femoral stretch test.
排除标准
- •Body Mass Index (BMI)>35kg.m2, documented history of allergic reaction to any of the study drugs, has clinically significant heart, lung, kidney or liver illness, has significant pain outside the area affected by the sciatica (radiculopathy), has had lumbar or sacral back surgery or plans for surgical intervention while in the study, has a documented history or Rheumatoid Arthritis or Inflammatory Arthritis, has had epidural corticosteroid injections in the back within 2 months of screening.
研究者
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