NCT02337062已完成3 期
Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,147
- 试验地点
- 25
- 主要终点
- Number of Participants With Complete Response
研究概览
简要总结
A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age
- •Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure
- •Patients with at least 3 "Apfel" risk factors for PONV
排除标准
- •Patients scheduled to undergo transplant surgery
- •Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
- •Patients who are expected to remain ventilated for a period after surgery
- •Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
研究组 & 干预措施
APD421 + standard anti-emetic
Experimental
Single dose of IV APD421
干预措施: APD421 (Drug)
Placebo + standard anti-emetic
Placebo Comparator
Single dose of IV placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Complete Response
时间窗: 24 hours after the end of surgery
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)
次要结局
- Number of Participants Receiving Rescue Medication(24 hours after the end of surgery)
- Number of Participants With Significant Nausea(24 hours after end of surgery)
- Time to First Violation of Criteria for PONV(24 hours after end of surgery)
- Number of Participants With Emesis(24 hours after the end of surgery)
- Number of Participants With Any Nausea(24 hours after the end of surgery)
研究者
研究点 (25)
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