<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482985</url>
  </required_header>
  <id_info>
    <org_study_id>2020-2019</org_study_id>
    <nct_id>NCT04482985</nct_id>
  </id_info>
  <brief_title>Meclizine Plasma Levels in Responders and Non-responders</brief_title>
  <official_title>Meclizine Plasma Levels in Responders and Non-responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Corps, Israel Defense Force</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Corps, Israel Defense Force</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Motion sickness is a debilitating condition that can effect many crew members. Meclizine has&#xD;
      long been known as an effective anti motion sickness drug. The response to the drug is&#xD;
      variable - some are responders, while others are resistant to the drug. The aim of the&#xD;
      present study is to examine whether there is a correlation between meclizine plasma levels&#xD;
      and clinical response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Meclizine plasma levels</measure>
    <time_frame>2 hours after meclizine administration</time_frame>
    <description>ng/dl</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Seasickness</condition>
  <condition>Meclizine</condition>
  <arm_group>
    <arm_group_label>Meclizine responders</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Meclizine non responders</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meclizine Hydrochloride</intervention_name>
    <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.</description>
    <arm_group_label>Meclizine non responders</arm_group_label>
    <arm_group_label>Meclizine responders</arm_group_label>
    <other_name>Bonine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Seasickness questioner (WIKER) score of 7.&#xD;
&#xD;
          -  Subjective functioning at 1 meter sea voyage - 5/10 and lower.&#xD;
&#xD;
          -  Subjects who were prescribed 25mg of meclizine.&#xD;
&#xD;
          -  Subjects who did not take any other drugs 48 prior to their participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hearing loss or any vestibular impairment&#xD;
&#xD;
          -  Vertigo complains&#xD;
&#xD;
          -  Any ear infection&#xD;
&#xD;
          -  Use of Scopolamine based anti-seasickness drugs.&#xD;
&#xD;
          -  Use of meclizine 50mg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yoni Evgeni Gutkovich, M.D/Ph.D</last_name>
    <phone>+972526894497</phone>
    <email>gutkovichj@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dror Tal, Ph.D</last_name>
    <phone>+972549096080</phone>
    <email>tldror1@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <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.</citation>
    <PMID>21163711</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Corps, Israel Defense Force</investigator_affiliation>
    <investigator_full_name>Yoni Gutkovich</investigator_full_name>
    <investigator_title>deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.</investigator_title>
  </responsible_party>
  <keyword>Seasickness</keyword>
  <keyword>Plasma Levels</keyword>
  <keyword>Meclizine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motion Sickness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meclizine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482985
org study id: 2020-2019
nct id: NCT04482985
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Meclizine plasma levels
time frame: 2 hours after meclizine administration
description: ng/dl
arm group label: Meclizine responders
arm group type: Active Comparator
arm group label: Meclizine non responders
arm group type: Active Comparator
intervention type: Drug
intervention name: Meclizine Hydrochloride
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.
arm group label: Meclizine non responders
arm group label: Meclizine responders
other name: Bonine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yoni Evgeni Gutkovich, M.D/Ph.D
phone: +972526894497
email: gutkovichj@gmail.com
last name: Dror Tal, Ph.D
phone: +972549096080
email: tldror1@gmail.com
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.
PMID: 21163711
responsible party type: Principal Investigator
investigator affiliation: Medical Corps, Israel Defense Force
investigator full name: Yoni Gutkovich
investigator title: deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.
mesh term: Motion Sickness
mesh term: Meclizine
sharing ipd: No