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临床试验/NCT00092196
NCT00092196已完成3 期

Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Merck Sharp & Dohme LLC0 个研究点目标入组 820 人开始时间: 2002年12月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
820
主要终点
Safety and tolerability

研究概览

简要总结

The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
  • Patient must have completed participation in the main study for this protocol.

排除标准

  • Patient has a central nervous system malignancy.
  • Patient will receive radiation to the abdomen or pelvis.

结局指标

主要结局

Safety and tolerability

次要结局

  • Assessment of adverse experiences using the National Cancer Institute (NCI) criteria

研究者

申办方类型
Industry
责任方
Sponsor

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