Levo Phencynonate Hydrochloride for the Prevention of Seasickness

May 6, 2015 updated by: Sihuan Pharmaceutical Holdings Group Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China
        • Qingdao Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Placebo
Drug: placebo
placebo of levo phencynonate hydrochloride
EXPERIMENTAL: levo phencynonate hydrochloride 1mg
levo phencynonate hydrochloride tablet 1mg
Drug: placebo
placebo of levo phencynonate hydrochloride
Drug: levo phencynonate hydrochloride
levo phencynonate hydrochloride
EXPERIMENTAL: levo phencynonate hydrochloride 2mg
Drug: levo phencynonate hydrochloride
levo phencynonate hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two hours of voyage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Investigators

  • Principal Investigator: Weiguo Xue, Qingdao Municipal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (ESTIMATE)

September 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOJI-1423Q

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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