A Phase 4 interventional study of Bonine 25Mg Chewable Tablet and Kwells in Drug Reaction, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Medical Corps, Israel Defense Force · Phase 4, Interventional, and Other
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.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 54 is below the median of 108 across 262 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )
Drug: Kwells
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )
Drug: Kwells
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )
Drug: Bonine 25Mg Chewable Tablet
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )
Drug: Bonine 25Mg Chewable Tablet
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
Motion sickness drug
Also known as: Meclizine
Motion sickness drug
Also known as: Scopolamine
No active substance in the tablet
Also known as: Placebo
Vestibular Time Constant Change/differential
One of the parameters measured in step velocity test \[Sec\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Step Velocity Test Gain Change/differential
One of the parameters measured in step velocity test \[0-1\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Optokinetic After Nystagmus (OKAN) Gain Change/differential
One of the parameters measured in optokinetic test \[0-1\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Optokinetic After Nystagmus (OKAN) Time Constant Change/differential
One of the parameters measured in optokinetic test \[Sec\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
One of the parameters measured in optokinetic test \[Deg/Sec\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Pupil Size Change/differential
Using pupil size chart \[Mm\]
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Pupil Accommodation and Convergation Change/differential
Eye test for drugs side effects.
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Side Effects Questionnaire Change/differential
Questionnaire of drugs' side effects.
Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Plan to share: No
Ran from Jun 2017 to primary completion in Sep 2019, 27 months.
Of 18 phase 4 interventional studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 37. This study's 27 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Meclizine · Scopolamine
Drug-Related Side Effects and Adverse Reactions →
Medical Corps, Israel Defense Force