CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
Bonine 25Mg Chewable Tablet +2 moredrug
Likely dose
Bonine 25Mg Chewable Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03270839
NCT03270839Phase 4Completed

Motion Sickness Medications and Vestibular Time Constant

Medical Corps, Israel Defense Force·interventional·Posted Sep 1, 2017·Updated Oct 3, 2025

In Brief

A Phase 4 clinical trial evaluating Bonine 25Mg Chewable Tablet, Kwells, and 1 other intervention for Drug Reaction. Completed, enrolled 54 participants across 1 site.

Detailed Summary

Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate drug for the patient. Difficulties arise due to high variability in the response to different drugs. In the case of sea sickness, the current procedure is to examine the drug's efficacy in each individual during real time exposure to sea conditions. A number of studies have documented the presence of sea sickness drug receptors in the vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of the proposed study is to evaluate the influence of motion sickness drugs on the vestibular time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty crew members will be recruited and divided into groups responsive and non-responsive to the sea sickness drugs scopolamine and meclizine. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no improvement in symptoms after treatment will be defined as non-responsive to sea sickness drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy. Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours after drug or placebo administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Reaction
CountriesIsrael
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartJun 1, 2017
Primary CompletionSep 30, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.8 years ago

Interventions

Bonine 25Mg Chewable Tabletdrug

Motion sickness drug

Kwellsdrug

Motion sickness drug

Placebo Oral Tabletdrug

No active substance in the tablet