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Trial record 5 of 9 for:    MECLIZINE

Motion Sickness Medications and Vestibular Time Constant

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ClinicalTrials.gov Identifier: NCT03270839
Recruitment Status : Unknown
Verified August 2017 by Dror Tal, Medical Corps, Israel Defense Force.
Recruitment status was:  Recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dror Tal, 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.


Condition or disease Intervention/treatment Phase
Drug Reaction Drug: Bonine 25Mg Chewable Tablet Drug: Kwells Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Motion Sickness Medications and Vestibular Time Constant
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : May 1, 2018


Arm Intervention/treatment
Active Comparator: Responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Drug: Kwells
Motion sickness drug
Other Name: Scopolamine

Placebo Comparator: Responsive to Scopolamine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
No active substance in the tablet
Other Name: Placebo

Active Comparator: Non-responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Drug: Kwells
Motion sickness drug
Other Name: Scopolamine

Placebo Comparator: Non-responsive to Scopolamine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
No active substance in the tablet
Other Name: Placebo

Active Comparator: Responsive to Meclizine (Active)
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Drug: Bonine 25Mg Chewable Tablet
Motion sickness drug
Other Name: Meclizine

Placebo Comparator: Responsive to Meclizine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
No active substance in the tablet
Other Name: Placebo

Active Comparator: Non-responsive to Meclizine (Active)
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Drug: Bonine 25Mg Chewable Tablet
Motion sickness drug
Other Name: Meclizine

Placebo Comparator: Non-responsive to Meclizine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Drug: Placebo Oral Tablet
No active substance in the tablet
Other Name: Placebo




Primary Outcome Measures :
  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270839


Contacts
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Contact: Dror Tal, PhD +972549096080 tldror1@gmail.com

Locations
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Israel
Israeli Navy Medical Institute Recruiting
Haifa, Israel
Contact: Dror Tal, PhD    +972549096080    tldror1@gmail.com   
Sub-Investigator: Daniel Lagami, BSc         
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
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Principal Investigator: Dror Tal, PhD Head of Motion Sickness and Human Performance Laboratory, Principal Investigator

Publications:
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Responsible Party: Dror Tal, Head of Motion Sickness and Human Performance Laboratory, Principal Investigator, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT03270839     History of Changes
Other Study ID Numbers: 1723-2016
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Meclizine
Motion Sickness
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Signs and Symptoms
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents