A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 486
- 主要终点
- Complete response (CR) rates over 24 hours after the end of surgery
研究概览
简要总结
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
详细描述
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤75 years old; 18 < BMI≤30kg/m^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.
- •expected or agreed to stay in the hospital for 24 hours or more after surgery;
排除标准
- •diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
研究组 & 干预措施
Aprepitant Injection
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
干预措施: Aprepitant Injection (Drug)
Placebo
Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds
干预措施: Aprepitant Injection Placebo (Drug)
结局指标
主要结局
Complete response (CR) rates over 24 hours after the end of surgery
时间窗: 0-24 hours after the end of surgery
Complete response (defined as no emetic episodes and no use of rescue therapy)
次要结局
- Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery(0-24 hours after the end of surgery)
- Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery(0-24 hours after the end of surgery)
- Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery(0-24 hours after the end of surgery)
- Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery(0-48 hours after the end of surgery)
- Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery(0-24 hours after the end of surgery)
- Time to treatment failure in the 0 to 24 hours following the end of surgery(0-24 hours after the end of surgery)
- The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery(0-48 hours after the end of surgery)