NCT00212602已完成2 期
ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 11
- 主要终点
- Patient proportion of complete response (no vomiting and no rescue treatment).
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 20 years or older
- •Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours
- •Patients whose performance status is 0 to 2
- •Other inclusion criteria as specified in the study protocol
排除标准
- •In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
- •Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study
- •Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
- •Other exclusion criteria as specified in the study protocol
结局指标
主要结局
Patient proportion of complete response (no vomiting and no rescue treatment).
次要结局
- Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment.
研究者
研究点 (11)
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