NCT04482985Unknown4 期
Meclizine Plasma Levels in Responders and Non-responders
Medical Corps, Israel Defense Force0 个研究点目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- Meclizine plasma levels
研究概览
简要总结
Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seasickness questioner (WIKER) score of
- •Subjective functioning at 1 meter sea voyage - 5/10 and lower.
- •Subjects who were prescribed 25mg of meclizine.
- •Subjects who did not take any other drugs 48 prior to their participation in the study.
排除标准
- •Known hearing loss or any vestibular impairment
- •Vertigo complains
- •Any ear infection
- •Use of Scopolamine based anti-seasickness drugs.
- •Use of meclizine 50mg.
研究组 & 干预措施
Meclizine responders
Active Comparator
干预措施: Meclizine Hydrochloride (Drug)
Meclizine non responders
Active Comparator
干预措施: Meclizine Hydrochloride (Drug)
结局指标
主要结局
Meclizine plasma levels
时间窗: 2 hours after meclizine administration
ng/dl
次要结局
未报告次要终点
研究者
Yoni Gutkovich
deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.
Medical Corps, Israel Defense Force
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