Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Sihuan Pharmaceutical Group

Status and phase: Completed; Phase 2

Conditions: Motion Sickness

Treatments: Drug: levo phencynonate hydrochloride; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02241629

BOJI-1423Q

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

levo phencynonate hydrochloride 1mg

Experimental group

Description:

levo phencynonate hydrochloride tablet 1mg

Treatment:

Drug: placebo

Drug: levo phencynonate hydrochloride

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

levo phencynonate hydrochloride 2mg

Experimental group

Description:

levo phencynonate hydrochloride 2mg

Treatment:

Drug: levo phencynonate hydrochloride