NCT03952377终止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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 10
- 主要终点
- The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
研究概览
简要总结
This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 ≥5.0 and ≤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 at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
- •Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
- •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
研究组 & 干预措施
0.9% Sodium Chloride for Injection
Placebo Comparator
干预措施: Placebo (Drug)
12.5 mg SX600
Experimental
Low Dose
干预措施: SX600 (Drug)
25.0 mg SX600
Experimental
High Dose
干预措施: SX600 (Drug)
结局指标
主要结局
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
时间窗: Baseline to 60 days
次要结局
- Change in Functional Outcomes as Measured by Patient's Global Impression of Change(Baseline, 14, 30, 60, 90, 120, 150, and 180 days)
- Change From Baseline in Short Form 36 Questionnaire (SF-36)(Baseline, 14, 30, 60, 90, 120, 150, and 180 days)
- The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)(Baseline to 14, 30, 60, 90, 120, 150, and 180 days)
- Change in Functional Outcomes as Measured by the Oswestry Disability Index(Baseline, 14, 30, 60, 90, 120, 150, and 180 days)
- The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)(Baseline to 14, 30, 60, 90, 120, 150, and 180 days)
- Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain)(Day 14 through 180 days)
- Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary(Baseline through 180 days)
研究者
研究点 (10)
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