Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 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 in the prevention of PONV in patients at moderate-to-high risk of 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 and expected to require at least one overnight stay in hospital
排除标准
- •Patients scheduled for outpatient/day case surgery
- •Patients scheduled to undergo intra-thoracic, transplant or central nervous system 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
APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.
干预措施: APD421- Amisulpride for IV injection (Drug)
Placebo
Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia
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
The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.
次要结局
- Number of Participants With "Total Response"(24 hours after the end of surgery)
- Number of Participants With no Nausea.(24 hours after end of surgery)
- Number of Participants With no Emesis(24 hours after end of surgery)
- Number of Participants With no Use of Rescue Medication(24 hours after end of surgery)
- The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication(24 hours after the end of surgery)
- The Number of Participants With no Significant Nausea(24 hours after the end of surgery)