Clinical on the Safety and Effectiveness of Fosaprepitant Dimeglumine for Injection in the Prevention of Nausea and Vomiting Caused by Tumor Chemotherapy Drugs.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Safety of Fosaprepitant Dimeglumine
研究概览
简要总结
To evaluate the safety of Fosaprepitant Dimeglumine Injection for the prevention of nausea and vomiting caused by tumor chemotherapy drugs, analyze the characteristics of the applicable population and clinical medication of Fosaprepitant Dimeglumine, evaluate the risk factors that may affect the efficacy of drug use, and compare the clinical benefits of different drug use modes.
详细描述
This is a prospective, one arm, open, non-interference, multi center, observational, real world clinical study.
Study drug: Fosaprepitant Dimeglumine for injection. White or almost white lump or powder, containing 150mg (calculated as C23H22F7N4O6P). This product is a NK-1 receptor antagonist, which is administered jointly with other antiemetic drugs. It is suitable for adult patients to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetic chemotherapy drugs (HEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nausea and vomiting caused by chemotherapy
- •Patients who volunteered to participate in the study
排除标准
- •Hypersensitive to any component in this product
- •Patients taking pimozide, terfenadine, astemizole and cisapride
研究组 & 干预措施
Tumor chemotherapy patients
To evaluate the safety of Fosaprepitant Dimeglumine for injection in the prevention of nausea and vomiting caused by tumor chemotherapy drugs
干预措施: Fosaprepitant Dimeglumine for Injection (Drug)
结局指标
主要结局
Safety of Fosaprepitant Dimeglumine
时间窗: 7 day
Safety evaluation: observe the known adverse reactions (including those found in preclinical studies, clinical studies, previous routine monitoring, and those in the same product of aspirin) and whether there are new adverse reactions, and observe the incidence and occurrence of these adverse reactions (occurrence characteristics, severity, risk factors), At the same time, we should pay attention to the occurrence of adverse reactions of drugs used in special groups (pregnant women, children, the elderly, patients with liver and kidney dysfunction), and the safety of different chemotherapy schemes.
Effectiveness of Fosaprepitant Dimeglumine
时间窗: 7 day
Efficacy evaluation: complete control rate (CR), that is, the proportion of patients without vomiting and without remedial drugs; Including acute CR (0-24h) and delayed vomiting CR (25-120h). To evaluate the applicable population characteristics and clinical medication characteristics of fosapitam, observe the efficacy of fosapitam in different chemotherapy schemes, tumor types and different dosage schemes, preliminarily analyze the risk factors affecting the efficacy of fosapitam, and compare the clinical benefits of different medication modes.
次要结局
未报告次要终点