NCT01941563已完成3 期
A Study of SI-6603 in Patients With Lumbar Disc Herniation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 385
- 主要终点
- Leg pain
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
- •Patients assessed as positive in the SLR test.
- •Patients with sciatica in either leg.
- •Patients with no improvement from conservative treatment
排除标准
- •Patients who have 2 or more lumbar disc herniations as assessed by MRI.
- •Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
- •Patients who have received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
- •Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
研究组 & 干预措施
SI-6603
Experimental
SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
干预措施: Condoliase (Drug)
Control
Sham Comparator
Sham injection
干预措施: placebo (Drug)
结局指标
主要结局
Leg pain
时间窗: 13 weeks
Assessed by Visual Analog Scale (VAS)
次要结局
- Responder rate evaluation(13 weeks)
研究者
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