Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- the symptoms of seasickness
研究概览
简要总结
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.
详细描述
The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects fulfilling the diagnostic criteria for motion sickness
- •Have medical history for motion sickness
- •During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
- •Adults for 18-55 years, male or female.
- •Agree to participate the study and can sign the ICF independently.
排除标准
- •Be allergic to the study drug or be allergic constitution
- •ALT, AST≥ 1.5 times of ULN, Scr>ULN, or other clinical significant lab values.
- •Abnormal ECG which is clinical significant judged by investigators, including: QTc>normal range
- •Have medical history for urination disorder
- •Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
- •Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )
- •Have internal ear disease which may disturb the evaluation of motion sickness.
- •Have glaucoma or posterior circulation ischemia
- •Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.
- •Participated in other studies within the past 3 months.
研究组 & 干预措施
levo phencynonate hydrochloride 1mg
levo phencynonate hydrochloride tablet 1mg
干预措施: placebo (Drug)
levo phencynonate hydrochloride 1mg
levo phencynonate hydrochloride tablet 1mg
干预措施: levo phencynonate hydrochloride (Drug)
placebo
Placebo
干预措施: placebo (Drug)
levo phencynonate hydrochloride 2mg
levo phencynonate hydrochloride 2mg
干预措施: levo phencynonate hydrochloride (Drug)
结局指标
主要结局
the symptoms of seasickness
时间窗: Two hours of voyage
Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.
次要结局
未报告次要终点