NCT05903924已完成3 期
Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel
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
- 316
- 试验地点
- 5
- 主要终点
- Prevention of Vomiting Measured by Vomiting Assessment (VA)
研究概览
简要总结
A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in participants affected by motion sickness during travel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of motion sickness
- •Age 18-75
排除标准
- •Nausea-inducing disorder other than motion sickness
- •History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
研究组 & 干预措施
Tradipitant High Dose
Experimental
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Tradipitant Low Dose
Experimental
干预措施: Tradipitant (Drug)
结局指标
主要结局
Prevention of Vomiting Measured by Vomiting Assessment (VA)
时间窗: 1 day
Prevention of vomiting measured by Vomiting Assessment (VA) score. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited.
次要结局
未报告次要终点
研究者
研究点 (5)
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