NCT00272285已完成3 期
A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea
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
- 287
- 主要终点
- Proportion of patients without vomiting after the start of chemotherapy for 24 hours
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with age between 20-74 years old (inclusive) of either sex
- •Cancer subject is scheduled to receive the designated chemotherapy programs
- •Subject without symptoms of vomiting for at least one week before dosing trial medication
- •Subject with ECOG performance status scale no greater than 2
- •Subject has signed the written informed consent form
排除标准
- •Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
- •Subject has received the designated chemotherapy programs within 6 months before entering the study
- •Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
- •Subject has known concurrent diseases that may cause vomiting
- •Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
- •Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone
- •Female subject who is pregnant or breastfeeding
- •Subject with life expectancy less than 3 months
- •Subject participated other investigational drug trial within 1 month before entering this study
研究组 & 干预措施
2
Active Comparator
Intravenous (IV)
干预措施: Granisetron (Drug)
1
Experimental
Intravenous (IV)
干预措施: Ramosetron (Drug)
结局指标
主要结局
Proportion of patients without vomiting after the start of chemotherapy for 24 hours
时间窗: 1 Day
次要结局
- Response rate of vomiting prevention(1 Day)
- The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)(1 Day)
- The number of vomiting episodes(1 Day)
研究者
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