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Meclizine Plasma Levels in Responders and Non-responders

Primary Purpose

Seasickness, Meclizine

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meclizine Hydrochloride
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasickness focused on measuring Seasickness, Plasma Levels, Meclizine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Seasickness questioner (WIKER) score of 7.
  • Subjective functioning at 1 meter sea voyage - 5/10 and lower.
  • Subjects who were prescribed 25mg of meclizine.
  • Subjects who did not take any other drugs 48 prior to their participation in the study.

Exclusion Criteria:

  • Known hearing loss or any vestibular impairment
  • Vertigo complains
  • Any ear infection
  • Use of Scopolamine based anti-seasickness drugs.
  • Use of meclizine 50mg.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Meclizine responders

    Meclizine non responders

    Arm Description

    Outcomes

    Primary Outcome Measures

    Meclizine plasma levels
    ng/dl

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2020
    Last Updated
    July 19, 2020
    Sponsor
    Medical Corps, Israel Defense Force
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04482985
    Brief Title
    Meclizine Plasma Levels in Responders and Non-responders
    Official Title
    Meclizine Plasma Levels in Responders and Non-responders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    September 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical Corps, Israel Defense Force

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seasickness, Meclizine
    Keywords
    Seasickness, Plasma Levels, Meclizine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Meclizine responders
    Arm Type
    Active Comparator
    Arm Title
    Meclizine non responders
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Meclizine Hydrochloride
    Other Intervention Name(s)
    Bonine
    Intervention Description
    Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.
    Primary Outcome Measure Information:
    Title
    Meclizine plasma levels
    Description
    ng/dl
    Time Frame
    2 hours after meclizine administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Seasickness questioner (WIKER) score of 7. Subjective functioning at 1 meter sea voyage - 5/10 and lower. Subjects who were prescribed 25mg of meclizine. Subjects who did not take any other drugs 48 prior to their participation in the study. Exclusion Criteria: Known hearing loss or any vestibular impairment Vertigo complains Any ear infection Use of Scopolamine based anti-seasickness drugs. Use of meclizine 50mg.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yoni Evgeni Gutkovich, M.D/Ph.D
    Phone
    +972526894497
    Email
    gutkovichj@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dror Tal, Ph.D
    Phone
    +972549096080
    Email
    tldror1@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21163711
    Citation
    Wang Z, Qian S, Zhang Q, Chow MS. Quantification of meclizine in human plasma by high performance liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 1;879(1):95-9. doi: 10.1016/j.jchromb.2010.11.022. Epub 2010 Dec 1.
    Results Reference
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    Meclizine Plasma Levels in Responders and Non-responders

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