<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/NCT02253524</url>
  </required_header>
  <id_info>
    <org_study_id>PAU-1179</org_study_id>
    <nct_id>NCT02253524</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo</brief_title>
  <official_title>Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Vertigo complaint is one of the common cause of patients who applied to emergency&#xD;
           services.&#xD;
&#xD;
        -  Patients who have applied to emergency services with vertigo complaint mostly have&#xD;
           nausea as an additionally symptom to this complaint and anti-emetic agents can be used&#xD;
           in their treatments very often.&#xD;
&#xD;
        -  The investigators purpose is to investigate the advantages of Dimenhydrinate and&#xD;
           metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by&#xD;
           nausea&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Vertigo describes the illusion of being subject to an involuntary movement, usually&#xD;
           rotational, of the patient or the patient's surroundings which is caused by sudden tonic&#xD;
           neural activity.&#xD;
&#xD;
        -  The management and episodic treatment of patients with spontaneous vertigo related&#xD;
           nausea-vomiting symptoms are somewhat controversial in the emergency department setting.&#xD;
&#xD;
        -  Patients admitted to the emergency department with complaints of vertigo in addition to&#xD;
           a large portion of the symptoms are accompanied by nausea and antiemetic agents are&#xD;
           frequently used in the treatment.&#xD;
&#xD;
        -  An ideal treatment should be rapid in onset and effective, and lack debilitating side&#xD;
           effects.&#xD;
&#xD;
        -  Although a wide variety of classes of pharmacologic agents and modalities are used, the&#xD;
           emergency department treatment of acute spontaneous vertigo and associated with nausea-&#xD;
           vomiting has not been well studied.&#xD;
&#xD;
        -  It has been reported that the most commonly used medications for parenteral treatment of&#xD;
           vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and&#xD;
           metoclopramide (MTP).&#xD;
&#xD;
        -  It has a depressant action on hyper-stimulated labyrinthine function and antiemetic&#xD;
           effects, believed to be due to the antihistamine.&#xD;
&#xD;
        -  Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic&#xD;
           receptor function center of vestibular nucleus in the central vestibular system.&#xD;
&#xD;
        -  Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth&#xD;
           function by this means.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)</measure>
    <time_frame>Change from Baseline in nausea and vertigo scores at 30 minutes.</time_frame>
    <description>- participants will be followed for the duration of hospital stay, an expected average of 30 minutes.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Nausea</condition>
  <condition>Vomiting</condition>
  <condition>Vertigo</condition>
  <arm_group>
    <arm_group_label>Dimenhydrinate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metoclopramide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dimenhydrinate</intervention_name>
    <description>50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes</description>
    <arm_group_label>Dimenhydrinate</arm_group_label>
    <other_name>Dramamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoclopramide</intervention_name>
    <description>10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes</description>
    <arm_group_label>Metoclopramide</arm_group_label>
    <other_name>Primperan</other_name>
    <other_name>metpamid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18 to 65 years old patients,&#xD;
&#xD;
          -  had vertigo and accompanied nausea or vomiting [VAS (visual analog scale) score &gt;5]&#xD;
             during their emergency department episode of care for which the attending physician&#xD;
             recommended intravenous antiemetic medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal vital signs,&#xD;
&#xD;
          -  women who were pregnant or lactation,&#xD;
&#xD;
          -  those with a history of epilepsy,&#xD;
&#xD;
          -  acute psychiatric symptoms,&#xD;
&#xD;
          -  organic brain disease,&#xD;
&#xD;
          -  parkinson's disease or phaeochromocytoma,&#xD;
&#xD;
          -  or any known allergy to the study drugs,&#xD;
&#xD;
          -  uncooperative individuals,&#xD;
&#xD;
          -  use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous&#xD;
             fluids during the emergency department episode of care,&#xD;
&#xD;
          -  currently undergoing chemotherapy or radiotherapy,&#xD;
&#xD;
          -  mechanical obstruction or perforation,&#xD;
&#xD;
          -  gastrointestinal bleeding,&#xD;
&#xD;
          -  inability to understand study explanation or outcome measures (any reason),&#xD;
&#xD;
          -  known allergy or previous adverse reaction to metoclopramide or dimenhydrinate,&#xD;
&#xD;
          -  and patients who refused to participate study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bulent ERDUR, proffessor</last_name>
    <role>Study Director</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 27, 2014</last_update_submitted>
  <last_update_submitted_qc>September 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Bulent Erdur</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>Metoclopramide</keyword>
  <keyword>Dimenhydrinate</keyword>
  <keyword>emergency medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoclopramide</mesh_term>
    <mesh_term>Dimenhydrinate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02253524
org study id: PAU-1179
nct id: NCT02253524
lead sponsor: 
has dmc: Yes
-  Vertigo complaint is one of the common cause of patients who applied to emergency
           services.

        -  Patients who have applied to emergency services with vertigo complaint mostly have
           nausea as an additionally symptom to this complaint and anti-emetic agents can be used
           in their treatments very often.

        -  The investigators purpose is to investigate the advantages of Dimenhydrinate and
           metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by
           nausea
-  Vertigo describes the illusion of being subject to an involuntary movement, usually
           rotational, of the patient or the patient's surroundings which is caused by sudden tonic
           neural activity.

        -  The management and episodic treatment of patients with spontaneous vertigo related
           nausea-vomiting symptoms are somewhat controversial in the emergency department setting.

        -  Patients admitted to the emergency department with complaints of vertigo in addition to
           a large portion of the symptoms are accompanied by nausea and antiemetic agents are
           frequently used in the treatment.

        -  An ideal treatment should be rapid in onset and effective, and lack debilitating side
           effects.

        -  Although a wide variety of classes of pharmacologic agents and modalities are used, the
           emergency department treatment of acute spontaneous vertigo and associated with nausea-
           vomiting has not been well studied.

        -  It has been reported that the most commonly used medications for parenteral treatment of
           vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and
           metoclopramide (MTP).

        -  It has a depressant action on hyper-stimulated labyrinthine function and antiemetic
           effects, believed to be due to the antihistamine.

        -  Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic
           receptor function center of vestibular nucleus in the central vestibular system.

        -  Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth
           function by this means.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)
time frame: Change from Baseline in nausea and vertigo scores at 30 minutes.
description: - participants will be followed for the duration of hospital stay, an expected average of 30 minutes.
arm group label: Dimenhydrinate
arm group type: Active Comparator
description: 50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
arm group label: Metoclopramide
arm group type: Active Comparator
description: 10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
intervention type: Drug
intervention name: Dimenhydrinate
description: 50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
arm group label: Dimenhydrinate
other name: Dramamine
intervention type: Drug
intervention name: Metoclopramide
description: 10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
arm group label: Metoclopramide
other name: Primperan
other name: metpamid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bulent ERDUR, proffessor
role: Study Director
affiliation: Pamukkale University
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Bulent Erdur
investigator title: Assoc. Prof.
mesh term: Vertigo
mesh term: Nausea
mesh term: Vomiting
mesh term: Dizziness
mesh term: Metoclopramide
mesh term: Dimenhydrinate