JPRN-UMIN000017576已完成2 期
Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703 - Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Hokkaido Gastrointestinal Cancer Study Group (HGCSG)0 个研究点目标入组 40 人开始时间: 2015年5月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Proportions of patients with complete protection from vomiting were 85.7% (95% confidence interval (CI), 63.7-97.0%) with the 3-day regimen, and 81.0% (95%CI, 58.1-94.6%) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95%CI, 25.7-70.2%). No rescue therapy rates were 66.7% (95%CI, 43.0-85.4%) vs. 57.1% (95%CI, 34.0-78.2%). No severe adverse events were observed in either arm.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. had any known central nervous system malignancy 2. had any seizure disorder needing anticovulsants 3. had active gastrointestinal ulcers or obstruction 4. had any other organic cause of nausea or vomiting unrelated to chemotherapy 5. were scheduled to undergo radiotherapy 6. were pregnant or nursing women 7. had any history of drug hypersensitivity
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