Motion Sickness Medications and Vestibular Time Constant

Medical Corps, Israel Defense Force

Status and phase: Unknown; Phase 4

Conditions: Drug Reaction

Treatments: Drug: Placebo Oral Tablet; Drug: Kwells; Drug: Bonine 25Mg Chewable Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03270839

1723-2016

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 8 patient groups, including a placebo group

Responsive to Scopolamine (Active)

Active Comparator group

Description:

Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )

Treatment:

Drug: Kwells

Responsive to Scopolamine (Placebo)

Placebo Comparator group

Description:

Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

Treatment:

Drug: Placebo Oral Tablet

Non-responsive to Scopolamine (Active)

Active Comparator group

Description:

Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )

Treatment:

Drug: Kwells

Non-responsive to Scopolamine (Placebo)

Placebo Comparator group

Description:

Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

Treatment:

Drug: Placebo Oral Tablet

Responsive to Meclizine (Active)

Active Comparator group

Description:

Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )

Treatment:

Drug: Bonine 25Mg Chewable Tablet

Responsive to Meclizine (Placebo)

Placebo Comparator group

Description:

Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

Treatment:

Drug: Placebo Oral Tablet

Non-responsive to Meclizine (Active)

Active Comparator group

Description:

Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )

Treatment:

Drug: Bonine 25Mg Chewable Tablet

Non-responsive to Meclizine (Placebo)

Placebo Comparator group

Description:

Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

Treatment:

Drug: Placebo Oral Tablet