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临床试验/NCT00169572
NCT00169572已完成2 期

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GlaxoSmithKline52 个研究点 分布在 19 个国家目标入组 492 人开始时间: 2005年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
492
试验地点
52
主要终点
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

研究概览

简要总结

This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

详细描述

Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

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
Double

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

次要结局

  • Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

研究者

申办方类型
Industry

研究点 (52)

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