A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Achivement of Target Sedation
研究概览
简要总结
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.
The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.).
排除标准
- •involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
- •Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
- •Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
- •Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)
- •ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.
研究组 & 干预措施
Group 1
Group 1 (placebo group) is treated by Anaesthesiologist
干预措施: Intralipid (Drug)
Group 2
Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
干预措施: ICI35,868 (Diprivan) (Drug)
Group 3
Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
干预措施: ICI35,868 (Diprivan) + EES0000645/A (SDS) (Drug)
结局指标
主要结局
Achivement of Target Sedation
时间窗: from scope-in to scope-out
The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.
次要结局
- PSSI Total Score(at 24-48 h after endoscopy)