NCT00634946已完成2 期
A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III 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
- 195
- 试验地点
- 8
- 主要终点
- Changes in leg pain from baseline.
研究概览
简要总结
The purpose of this study is to determine whether SI-6603 is effective in the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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
I
Experimental
干预措施: SI-6603 (Drug)
II
Experimental
干预措施: SI-6603 (Drug)
III
Experimental
干预措施: SI-6603 (Drug)
IV
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in leg pain from baseline.
时间窗: 13 weeks
次要结局
- The leg pain(At each assessment time point)
研究者
研究点 (8)
Loading locations...
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