A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of Ramosetron according to 3 level of dose
研究概览
简要总结
This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.
详细描述
Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who recevied moderate emetogenic chemotherapy
- •Age between 18-75
- •ECOG PS 0-2
- •Adequate organ fuction including bone marrow, liver and kidney
排除标准
- •Gastrointestinal obstruction or carcinomatosis peritonei
- •CNS metastasis or disability in CNS
- •Intractable medical illness
- •Pregnancy or inadequate contraception
研究组 & 干预措施
Ramosetron 0.3mg
Ramosetron 0.3mg intravenous injection 30 min before chemotherapy
干预措施: Ramosetron 0.3mg (Drug)
Ramosetron 0.6mg
Ramosetron 0.6mg intravenous injection 30min before chemotherapy
干预措施: Ramosetron 0.6mg (Drug)
Ramosetron 0.45mg
Ramosetron 0.45mg intravenous injection 30min before chemotherapy
干预措施: Ramosetron 0.45mg (Drug)
结局指标
主要结局
Pharmacokinetic profile of Ramosetron according to 3 level of dose
时间窗: 10min to 48 hours post-dose
Pharmacokinectics using NONMEM will be analyzed from serum after Ramosetron injection from 10 min to 48 hours (10min, 1hr, 6hr, 24hr, 48hr)
次要结局
- Rhodes Index(1 hour to seven days post-dose)
研究者
Sang-Hee Cho
Assistant Professor
Chonnam National University Hospital