Drug ReactionPhase 4NCT03270839
Motion Sickness Medications and Vestibular Time Constant
A Phase 4 study testing Bonine 25Mg Chewable Tablet and Kwells in people with Drug Reaction, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Reaction
- What is being tested?
- Bonine 25Mg Chewable Tablet and Kwells
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2017to 1 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness
- 48 hours prior to session without any use of medications
- Soldiers who vomit in waves 1.5 meter high without drugs treatment
Who cannot join
- Anamnestic hearing Impairment
- Ear infection of any kind
- Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment.
- Vision pathologies the interfere with VNG test.
- Withdrawal of informed consent by the patient of any cause.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Drug Reaction
- Being tested
- Bonine 25Mg Chewable Tablet, Kwells, Placebo Oral Tablet
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonine 25Mg Chewable TabletDrug
Also called Meclizine
Motion sickness drug
KwellsDrug
Also called Scopolamine
Motion sickness drug
Placebo Oral TabletDrug
Also called Placebo
No active substance in the tablet
| Study group | Role | What they receive |
|---|---|---|
| Responsive to Scopolamine (Active) | Active comparator | Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) Receives: Drug: Kwells |
| Responsive to Scopolamine (Placebo) | Placebo comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) Receives: Drug: Placebo Oral Tablet |
| Non-responsive to Scopolamine (Active) | Active comparator | Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) Receives: Drug: Kwells |
| Non-responsive to Scopolamine (Placebo) | Placebo comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) Receives: Drug: Placebo Oral Tablet |
| Responsive to Meclizine (Active) | Active comparator | Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) Receives: Drug: Bonine 25Mg Chewable Tablet |
| Responsive to Meclizine (Placebo) | Placebo comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) Receives: Drug: Placebo Oral Tablet |
| Non-responsive to Meclizine (Active) | Active comparator | Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) Receives: Drug: Bonine 25Mg Chewable Tablet |
| Non-responsive to Meclizine (Placebo) | Placebo comparator | Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular Time Constant Change/differential
One of the parameters measured in step velocity test [Sec]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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.
Measured: 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.
Measured: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Jun 2017
- Primary completion30 Sep 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Drug ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dror Tal, Medical Corps, Israel Defense Force
- Investigators
- Dror Tal, PhD, Principal investigator, Head of Motion Sickness and Human Performance Laboratory, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270839
- Sponsor's protocol ID
- 1723-2016
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2017
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheung BS, Howard IP, Money KE. Visually-induced sickness in normal and bilaterally labyrinthine-defective subjects. Aviat Space Environ Med. 1991 Jun;62(6):527-31.
PubMed 1859339Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2.
PubMed 21287155Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163.
PubMed 25502048Ishiyama A, Lopez I, Wackym PA. Molecular characterization of muscarinic receptors in the human vestibular periphery. Implications for pharmacotherapy. Am J Otol. 1997 Sep;18(5):648-54.
PubMed 9303164Phelan KD, Nakamura J, Gallagher JP. Histamine depolarizes rat medial vestibular nucleus neurons recorded intracellularly in vitro. Neurosci Lett. 1990 Feb 16;109(3):287-92. doi: 10.1016/0304-3940(90)90009-x.
PubMed 2139500Pyykko I, Schalen L, Matsuoka I. Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus. Acta Otolaryngol. 1985 May-Jun;99(5-6):597-604. doi: 10.3109/00016488509182266.
PubMed 4024910Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8.
PubMed 17726280Bar R, Gil A, Tal D. Safety of double-dose transdermal scopolamine. Pharmacotherapy. 2009 Sep;29(9):1082-8. doi: 10.1592/phco.29.9.1082.
PubMed 19698013
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Sickness Medications and Vestibular Time Constant
- ClinicalTrials.gov ID
- NCT03270839
- Acronym / sponsor ID
- 1723-2016
- Conditions
- Drug Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Responsive to Scopolamine (Active) | Active comparator | Drug: KwellsScopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) |
| Responsive to Scopolamine (Placebo) | Placebo comparator | Drug: Placebo Oral TabletPlacebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
| Non-responsive to Scopolamine (Active) | Active comparator | Drug: KwellsScopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) |
| Non-responsive to Scopolamine (Placebo) | Placebo comparator | Drug: Placebo Oral TabletPlacebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
| Responsive to Meclizine (Active) | Active comparator | Drug: Bonine 25Mg Chewable TabletMeclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) |
| Responsive to Meclizine (Placebo) | Placebo comparator | Drug: Placebo Oral TabletPlacebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
| Non-responsive to Meclizine (Active) | Active comparator | Drug: Bonine 25Mg Chewable TabletMeclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) |
| Non-responsive to Meclizine (Placebo) | Placebo comparator | Drug: Placebo Oral TabletPlacebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness
- 48 hours prior to session without any use of medications
- Soldiers who vomit in waves 1.5 meter high without drugs treatment
Key exclusion criteria (5 listed)
- Anamnestic hearing Impairment
- Ear infection of any kind
- Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment.
- Vision pathologies the interfere with VNG test.
- Withdrawal of informed consent by the patient of any cause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bonine 25Mg Chewable TabletAlso: MeclizineMotion sickness drug | Drug | Non-responsive to Meclizine (Active), Responsive to Meclizine (Active) |
| KwellsAlso: ScopolamineMotion sickness drug | Drug | Non-responsive to Scopolamine (Active), Responsive to Scopolamine (Active) |
| Placebo Oral TabletAlso: PlaceboNo active substance in the tablet | Drug | Non-responsive to Meclizine (Placebo), Non-responsive to Scopolamine (Placebo), Responsive to Meclizine (Placebo), Responsive to Scopolamine (Placebo) |
Primary outcome
Vestibular Time Constant Change/differential
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.
One of the parameters measured in step velocity test [Sec]
Step Velocity Test Gain Change/differential
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.
One of the parameters measured in step velocity test [0-1]
Optokinetic After Nystagmus (OKAN) Gain Change/differential
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.
One of the parameters measured in optokinetic test [0-1]
Optokinetic After Nystagmus (OKAN) Time Constant Change/differential
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.
One of the parameters measured in optokinetic test [Sec]
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
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.
One of the parameters measured in optokinetic test [Deg/Sec]
Pupil Size Change/differential
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.
Using pupil size chart [Mm]
Pupil Accommodation and Convergation Change/differential
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.
Eye test for drugs side effects.
Side Effects Questionnaire Change/differential
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.
Questionnaire of drugs' side effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 1859339Cheung BS, Howard IP, Money KE. Visually-induced sickness in normal and bilaterally labyrinthine-defective subjects. Aviat Space Environ Med. 1991 Jun;62(6):527-31.
- Background: PubMed 21287155Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2.
- Background: PubMed 25502048Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163.
- Background: PubMed 9303164Ishiyama A, Lopez I, Wackym PA. Molecular characterization of muscarinic receptors in the human vestibular periphery. Implications for pharmacotherapy. Am J Otol. 1997 Sep;18(5):648-54.
- Background: PubMed 2139500Phelan KD, Nakamura J, Gallagher JP. Histamine depolarizes rat medial vestibular nucleus neurons recorded intracellularly in vitro. Neurosci Lett. 1990 Feb 16;109(3):287-92. doi: 10.1016/0304-3940(90)90009-x.
- Background: PubMed 4024910Pyykko I, Schalen L, Matsuoka I. Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus. Acta Otolaryngol. 1985 May-Jun;99(5-6):597-604. doi: 10.3109/00016488509182266.
- Background: PubMed 17726280Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8.
- Background: PubMed 19698013Bar R, Gil A, Tal D. Safety of double-dose transdermal scopolamine. Pharmacotherapy. 2009 Sep;29(9):1082-8. doi: 10.1592/phco.29.9.1082.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror Tal, PhD principal investigator
Head of Motion Sickness and Human Performance Laboratory, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bonine 25Mg Chewable Tablet and Kwells in people with Drug Reaction, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular Time Constant Change/differential (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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270839, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.