NCT00828295已完成3 期
A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric 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
- 150
- 试验地点
- 13
- 主要终点
- Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
研究概览
简要总结
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.
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
- 28 Days 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1 mcg/kg arm
Experimental
Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)
干预措施: palonosetron (Drug)
3 mcg/kg arm
Experimental
Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)
干预措施: palonosetron (Drug)
结局指标
主要结局
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
时间窗: 0-72 hours post-operatively
次要结局
- Proportion of Patients With Complete Response 0-24 Hours(0-24 hours)
研究者
研究点 (13)
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