Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Study Overview
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Brief Summary
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A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

Detailed Description
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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.

Official Title
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Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study

Conditions
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Motion Sickness

Intervention / Treatment
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* Drug: placebo
* Drug: levo phencynonate hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levo phencynonate hydrochloride 1mg<br>levo phencynonate hydrochloride tablet 1mg | Drug: placebo<br>* placebo of levo phencynonate hydrochloride<br>Drug: levo phencynonate hydrochloride<br>* levo phencynonate hydrochloride<br>|
| Placebo Comparator: placebo<br>Placebo | Drug: placebo<br>* placebo of levo phencynonate hydrochloride<br>|
| Experimental: levo phencynonate hydrochloride 2mg<br>levo phencynonate hydrochloride 2mg | Drug: levo phencynonate hydrochloride<br>* levo phencynonate hydrochloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the symptoms of seasickness | Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale. | Two hours of voyage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motion sickness