NCT03772340已完成2 期
Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- The Most Severe Motion Sickness Severity During Vehicle Travel
研究概览
简要总结
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of 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
- 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
- •Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
- •Body Mass Index (BMI) of ≥18 and <40 kg/m2;
- •History or symptoms consistent with motion sickness
排除标准
- •Chronic nausea due to condition other than motion sickness;
- •A positive test for drugs of abuse at the screening or evaluation visits;
- •Clinically significant deviation from normal clinical laboratory results
研究组 & 干预措施
Tradipitant
Experimental
干预措施: Tradipitant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Most Severe Motion Sickness Severity During Vehicle Travel
时间窗: 1 day
As measured by the Motion Sickness Severity Scale (MSSS) (NRS 0-6); Lower score indicates improvement
Percentage of Vomiting
时间窗: 1 day
Defined as subjects ever vomited (MSSS=6) or terminated early due to severity during the vehicle travel. As measured by the Motion Sickness Severity Scale (NRS 0-6).
次要结局
未报告次要终点
研究者
研究点 (1)
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