NCT03727100已完成3 期
A Prospective, Multicenter, Randomized, Double-Blinded, Sham-Control Study to Evaluate the Efficacy and Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 65
- 主要终点
- Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
研究概览
简要总结
This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.
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)
盲法说明
Double-Blinded
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
- •Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
- •Diagnosis of unilateral radicular leg pain.
- •Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
- •Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
- •Agrees to follow study-specific medication requirements.
- •Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
- •Subject must have failed at least one conservative therapy in two different categories.
排除标准
- •Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
- •Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
- •Female subjects who are pregnant or breastfeeding.
- •History of lumbar surgery.
结局指标
主要结局
Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain
时间窗: Baseline to day 60
Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.
次要结局
- Change in Oswestry Disability Index (ODI) score(Baseline to day 30)
- Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection.(1 day post injection)
- Percent of subjects with significant improvement in pain(Baseline to day 30)
- Difference in Rescue medication consumption(Baseline to day 30)
研究者
研究点 (65)
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