Levo Phencynonate Hydrochloride for the Prevention of Seasickness

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02241629

Enrollment

180

Registered

2014-09-16

Start date

2014-08-31

Completion date

2015-02-28

Last updated

2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motion Sickness

Keywords

motion sickness

Brief summary

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

Detailed description

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.

Interventions

DRUGplacebo

placebo of levo phencynonate hydrochloride

DRUGlevo phencynonate hydrochloride

levo phencynonate hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026