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Levo Phencynonate Hydrochloride for the Prevention of Seasickness

Primary Purpose

Motion Sickness

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
placebo
levo phencynonate hydrochloride
Sponsored by
Sihuan Pharmaceutical Holdings Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Motion Sickness focused on measuring motion sickness

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Qingdao municipal hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

levo phencynonate hydrochloride 1mg

placebo

levo phencynonate hydrochloride 2mg

Arm Description

levo phencynonate hydrochloride tablet 1mg

Placebo

levo phencynonate hydrochloride 2mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2014
Last Updated
May 6, 2015
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02241629
Brief Title
Levo Phencynonate Hydrochloride for the Prevention of Seasickness
Official Title
Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
motion sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
levo phencynonate hydrochloride 1mg
Arm Type
Experimental
Arm Description
levo phencynonate hydrochloride tablet 1mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
levo phencynonate hydrochloride 2mg
Arm Type
Experimental
Arm Description
levo phencynonate hydrochloride 2mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo of levo phencynonate hydrochloride
Intervention Type
Drug
Intervention Name(s)
levo phencynonate hydrochloride
Intervention Description
levo phencynonate hydrochloride
Primary Outcome Measure Information:
Title
the symptoms of seasickness
Description
Investigators should assess the symptoms of seasickness for subjects according to sea sickness severity scale.
Time Frame
Two hours of voyage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiguo Xue
Organizational Affiliation
Qingdao Municipal Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qingdao municipal hospital
City
Qingdao
State/Province
Shandong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Levo Phencynonate Hydrochloride for the Prevention of Seasickness

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