A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting

Merck Sharp & Dohme LLC0 个研究点目标入组 805 人开始时间: 2003年9月26日最近更新: 2017年5月5日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 805
主要终点: Prevention of PONV in the 24 hours following end of surgery; Tolerability

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

详细描述

The duration of treatment is 4 weeks.

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: Double (Participant, Investigator)

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

•Patient is at least 18 years of age.
•Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
•Patient is scheduled to receive general anesthesia.
•Patient is scheduled to receive postoperative medication.

排除标准

未提供

结局指标

主要结局

Prevention of PONV in the 24 hours following end of surgery; Tolerability

次要结局

未报告次要终点

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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