Motion Sickness Medications and Vestibular Time Constant

Phase 4

• Conditions: Drug Reaction
• Interventions: Drug: Bonine 25Mg Chewable Tablet; Drug: Kwells; Drug: Placebo Oral Tablet

• Registration Number: NCT03270839
• Lead Sponsor: Medical Corps, Israel Defense Force

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-02
• Study Start: 2017-06-01
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Responsive to Meclizine (Active)	Bonine 25Mg Chewable Tablet	Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )
Non-responsive to Scopolamine (Active)	Kwells	Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )
Non-responsive to Meclizine (Placebo)	Placebo Oral Tablet	Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Responsive to Scopolamine (Active)	Kwells	Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )
Responsive to Scopolamine (Placebo)	Placebo Oral Tablet	Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Non-responsive to Scopolamine (Placebo)	Placebo Oral Tablet	Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Responsive to Meclizine (Placebo)	Placebo Oral Tablet	Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Non-responsive to Meclizine (Active)	Bonine 25Mg Chewable Tablet	Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )

Primary Outcome Measures

Name	Time	Method
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential	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 Accommodation and Convergation Change/differential	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.
Vestibular Time Constant Change/differential	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	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	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	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 \[Sec\]
Pupil Size Change/differential	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 \[Mm\]
Side Effects Questionnaire Change/differential	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.

Trial Locations

Locations (1)

Israeli Navy Medical Institute; 🇮🇱 Haifa, Israel