NCT01282606已完成2 期
An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
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
- 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 lower leg.
- •Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.
排除标准
- •Patients who have 2 or more lumbar disc herniations as assessed by MRI.
- •Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
- •Patients who have received nerve block within 3 weeks before screening.
- •Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.
研究组 & 干预措施
Drug I: SI-6603 (Low)
Experimental
干预措施: SI-6603 (Drug)
Drug II: SI-6603 (Middle)
Experimental
干预措施: SI-6603 (Drug)
Drug III: SI-6603 (High)
Experimental
干预措施: SI-6603 (Drug)
结局指标
主要结局
Adverse events
时间窗: 52 weeks
次要结局
- The leg pain(At each assessment time point)
研究者
研究点 (1)
Loading locations...
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