Trial | NCT02241629  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    levophencynonate ...

  • Study Participants

    180
A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.
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 Started
Aug 31
2014
Primary Completion
Dec 31
2014
Study Completion
Feb 28
2015
Last Update
May 07
2015
Estimate

Drug placebo

placebo of levo phencynonate hydrochloride

Drug levo phencynonate hydrochloride

levo phencynonate hydrochloride

levo phencynonate hydrochloride 1mg Experimental

levo phencynonate hydrochloride tablet 1mg

placebo Placebo Comparator

Placebo

levo phencynonate hydrochloride 2mg Experimental

levo phencynonate hydrochloride 2mg

Criteria 

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.
No Results Posted