Phase II Clinical Study of SyB D-0701 for Radiotherapy Induced Nausea and Vomiting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 4
- 主要终点
- Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
研究概览
简要总结
The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.
详细描述
Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SyB D-0701: high dose group
干预措施: SyB D-0701 (Drug)
SyB D-0701: low dose group
干预措施: SyB D-0701 (Drug)
SyB D-0701: low dose group
干预措施: Placebo (Drug)
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation
时间窗: 72 hours
The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.
次要结局
- Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation(72 hours)
- Time to First Emesis(24-72 hours)
- Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3(24-72 hours)
- Severe (Grade 3 or More) Adverse Events(Up to 192 hours)
- Adverse Events(Up to 192 hours)
- Skin Manifestations at Study Drug Application Site(Up to 192 hours)
- Time to First Nausea(24-72 hours)
- Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3(24-72 hours)