Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 37
- 主要终点
- Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
研究概览
简要总结
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment.
The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
- •Age 18 to 70 years (inclusive) at the Screening Visit.
- •A diagnosis of lumbosacral radicular pain (sciatica).
- •Agrees to follow study-specific medication requirements.
- •If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
- •Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.
排除标准
- •Has radiologic evidence of a condition that would compromise study outcomes.
- •Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
- •Has been diagnosed with insulin dependent diabetes mellitus.
- •Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
- •Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
- •Has a body mass index ≥40 kg/m2.
研究组 & 干预措施
SP-102
SP-102
干预措施: SP-102 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
时间窗: Baseline, 4 Weeks
The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
次要结局
- Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)(Baseline, 4 Weeks)