Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Phase 2

Completed

• Conditions: Motion Sickness
• Interventions: Drug: placebo; Drug: levo phencynonate hydrochloride

• Registration Number: NCT02241629
• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

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.

Study Timeline

• Study Start: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levo phencynonate hydrochloride 1mg	placebo	levo phencynonate hydrochloride tablet 1mg
levo phencynonate hydrochloride 1mg	levo phencynonate hydrochloride	levo phencynonate hydrochloride tablet 1mg
levo phencynonate hydrochloride 2mg	levo phencynonate hydrochloride	levo phencynonate hydrochloride 2mg
placebo	placebo	Placebo

Primary Outcome Measures

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

Trial Locations

Locations (1)

Qingdao municipal hospital; 🇨🇳 Qingdao, Shandong, China