NCT01991821已完成3 期
Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
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
- 368
- 试验地点
- 2
- 主要终点
- Complete Response (no Emesis, Significant Nausea or Rescue Medication)
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
Experimental
IV APD421 single dose
干预措施: APD421 (Drug)
Placebo
Placebo Comparator
IV placebo single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Response (no Emesis, Significant Nausea or Rescue Medication)
时间窗: 24 hours after end of surgery
The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.
次要结局
- Total Response (no Emesis, Nausea or Rescue Medication)(24 hrs after end of surgery)
- Use of Rescue Medication(24 hours after end of surgery)
- Complete Response (no Emesis or Rescue Medication)(24 hrs after end of surgery)
- Incidence of Emesis (Vomiting/Retching)(24 hours after end of surgeryry)
- Incidence of Significant Nausea(24 hours after end of surgery)
- Incidence of Nausea(24 hours after end of surgery)
研究者
研究点 (2)
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