NCT03773042已完成2 期
A Phase IIa, Multi-center, Open-label, Non-randomized, Active-controlled, and Dose-escalation Clinical Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion for Sedation/Anesthesia in Patients Undergoing Diagnostic Colonoscopy
Sichuan Haisco Pharmaceutical Group Co., Ltd1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Rate of successful colonoscopies.
研究概览
简要总结
A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HSK3486
Experimental
0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg
干预措施: HSK3486 (Drug)
Propofol
Active Comparator
1.0mg/kg, 2.0mg/kg
干预措施: Propofol (Drug)
结局指标
主要结局
Rate of successful colonoscopies.
时间窗: From the first dose of the study drug to removal of colonoscope on day 1
次要结局
- The success rate of the colonoscopy procedure(From the first dose of the study drug to removal of colonoscope on day 1)
- Time to fully alert(From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1)
- Application of study drug and alternative medication(During the colonoscopy procedure on day 1)
- Insertion time(From the first dose of study drug until insertion of colonoscope on day 1)
- Time to discharge(From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1)
- Mini-Mental State Examinations (MMSE)(During the screening and the colonoscopy procedure on day 1)
研究者
研究点 (1)
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