ACTRN12619001235190已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
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 65 Years（—）
- 性别
- All
入选标准
- •Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study
- •- Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy.
- •- Mean Worst Daily Leg Pain score of more than 5.0 and less than 9.0
- •- Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing
排除标准
- •- Documented history of allergy or intolerance to components of the Investigational
- •Medicinal Product, relevant radiologic contrast media, or local anaesthetics
- •- Is pregnant or lactating
- •- Has been taking corticosteroid medications routinely in the past 6 months or has
- •received an epidural corticosteroid injection within 12 weeks of screening
- •- Has a BMI greater than 40 kg/m2
- •- Has radiological evidence of clinically significant foraminal stenosis, spinal
- •stenosis, or spondylolisthesis
- •- Has Diabetes Mellitus (Type 1 or Type 2)
- •- Has a history of significant leg pain unrelated to disc herniation that would
- •significantly compromise assessment of back or leg radicular pain
- •- Has had lumbar back surgery
- •- Has received an implantable device for pain management
研究者
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