NCT02241629

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

September 12, 2014

Last Update Submit

May 6, 2015

Conditions

Motion Sickness

Keywords

motion sickness

Outcome Measures

Primary Outcomes (1)

  • the symptoms of seasickness

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

    Two hours of voyage

Study Arms (3)

levo phencynonate hydrochloride 1mg

EXPERIMENTAL

levo phencynonate hydrochloride tablet 1mg

Drug: placeboDrug: levo phencynonate hydrochloride

placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

levo phencynonate hydrochloride 2mg

EXPERIMENTAL

levo phencynonate hydrochloride 2mg

Drug: levo phencynonate hydrochloride

Interventions

placeboDRUG

placebo of levo phencynonate hydrochloride

levo phencynonate hydrochloride 1mgplacebo
levo phencynonate hydrochlorideDRUG

levo phencynonate hydrochloride

levo phencynonate hydrochloride 1mglevo phencynonate hydrochloride 2mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao municipal hospital

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Weiguo Xue

    Qingdao Municipal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

May 7, 2015

Record last verified: 2014-09

Locations

CN(1)