A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,011
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (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 undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
研究组 & 干预措施
SI-6603
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
干预措施: Condoliase (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
时间窗: 26 weeks
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented.
次要结局
- Worst Leg Pain as Assessed by Visual Analog Scale (VAS)(26 weeks)