Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

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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.

Conditions

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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levo phencynonate hydrochloride 1mg

levo phencynonate hydrochloride tablet 1mg

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

placebo of levo phencynonate hydrochloride

levo phencynonate hydrochloride

Intervention Type DRUG

levo phencynonate hydrochloride

placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo of levo phencynonate hydrochloride

levo phencynonate hydrochloride 2mg

Group Type EXPERIMENTAL

levo phencynonate hydrochloride

Intervention Type DRUG

levo phencynonate hydrochloride

Interventions

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placebo

placebo of levo phencynonate hydrochloride

Intervention Type DRUG

levo phencynonate hydrochloride

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes