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Completed

NCT Number: NCT02241629

Levo Phencynonate Hydrochloride for the Prevention of Seasickness

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

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Key information

Conditions

Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qingdao municipal hospital

Qingdao, Shandong, China

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

placebo of levo phencynonate hydrochloride

levo phencynonate hydrochloride

Drug

levo phencynonate hydrochloride

Primary outcomes

  1. the symptoms of seasickness

    Time frame: Two hours of voyage

    Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.

Sponsors and collaborators

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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