NCT00971399已完成3 期
Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer
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
- 172
- 试验地点
- 1
- 主要终点
- complete response of RINV (no vomiting and no rescue medication)
研究概览
简要总结
The purpose of this study is:
- To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
- To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •AJCC 1-3 staged gastrointestinal cancer patient
- •patient undergoing radiotherapy as treatment
- •age 20 yr and higher
排除标准
- •age < 20
- •patient experiencing nausea or vomiting prior to accrual
- •patient under antiemetic medication
- •patient under steroid medication (topical or inhalant steroid application are exceptional)
- •patient under opioid medication
研究组 & 干预措施
RMS
Experimental
ramosetron 0.1mg q.d. SL on D1-5
干预措施: ramosetron (Drug)
ODS
Active Comparator
ondansetron 8mg, b.i.d SL on D1-5
干预措施: ondansetron (Drug)
结局指标
主要结局
complete response of RINV (no vomiting and no rescue medication)
时间窗: 4 weeks after medication
次要结局
未报告次要终点
研究者
研究点 (1)
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