NCT03776318已完成不适用
A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 25
- 主要终点
- Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
研究概览
简要总结
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.
排除标准
- •Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
- •Subjects who were unblinded to their treatment in STX-015-18-01 study.
研究组 & 干预措施
Safety Group
STX-015-18-01 Clonidine Micropellet long-term safety follow-up
干预措施: Long-Term Safety Follow-up (Drug)
Sham Control
STX-015-18-01 Sham control long-term safety follow-up
干预措施: Long-Term Safety Follow-up (Drug)
结局指标
主要结局
Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
时间窗: 10 months from completing Day 60 of the STX-015-18-01 study
Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection
次要结局
- Incidence of Surgeries(12 months from day of injection)
- Incidence of Invasive treatment received(12 months from day of injection)
- Number of Prescription medications taken(12 months from day of injection)
研究者
研究点 (25)
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