NCT06138613进行中（未招募）3 期
Motion Delos: An Open Label Study to Investigate the Safety and 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
- 进行中（未招募）
- 入组人数
- 705
- 试验地点
- 2
- 主要终点
- Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).
研究概览
简要总结
An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel
详细描述
This is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.
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
- None
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
- •BMI > 40
- •History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
研究组 & 干预措施
Tradipitant Dose A
Experimental
"See Drug"
干预措施: Tradipitant (Drug)
Tradipitant Dose B
Experimental
"See Drug"
干预措施: Tradipitant (Drug)
结局指标
主要结局
Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).
时间窗: through study completion, approximately 1 year
Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, and ECGs.
次要结局
未报告次要终点
研究者
研究点 (2)
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