<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/NCT02213120</url>
  </required_header>
  <id_info>
    <org_study_id>BETA5003</org_study_id>
    <nct_id>NCT02213120</nct_id>
  </id_info>
  <brief_title>To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose &amp; Throat (ENT) Clinics.</brief_title>
  <acronym>VERTIGO</acronym>
  <official_title>To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dimension Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VERTIGO study is likely to help determine characteristics of different types of vertigo&#xD;
      in patients presenting in the Ear Nose &amp; Throat (ENT) clinics with complaints of dizziness.&#xD;
      Moreover, it will also help to develop an understanding about the current management&#xD;
      practices of this condition at local level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Characteristics (Different Types) of dizziness</measure>
    <time_frame>6 months</time_frame>
    <description>It will be determined that a patient with dizziness is suffering from what type of Vertigo i.e. Benign Paroxysmal Positional Vertigo, Menier's Disease, Vestibular Neuritis, Labyrinthitis or any other. As these are clinical types of Vertigo these cannot be measured in units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) of patients at baselines</measure>
    <time_frame>6 months</time_frame>
    <description>Dizziness Handicap Inventory will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Management of vertigo currently in practice</measure>
    <time_frame>6 months</time_frame>
    <description>As per practice of the physician/Investigator. Management of Vertigo is either by certain maneuvers such as Epley's and Simont or by medications. For the maneuvers, no unit can be defined. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL of patients post treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Dizziness Handicap Inventory will be used</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Vertigo</condition>
  <arm_group>
    <arm_group_label>Dizziness</arm_group_label>
    <description>Patients with Dizziness</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic/Private Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients 18 years of age and older&#xD;
&#xD;
          -  Patients with vestibular vertigo of known or unknown origin&#xD;
&#xD;
          -  Patients who are willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any condition which, in the opinion of the investigator, makes the&#xD;
             patient unsuitable for inclusion based on clinical judgment&#xD;
&#xD;
          -  Patient with psychiatric disorders, significant neurological disorder or spinal cord&#xD;
             damage that would make the evaluation difficult for the investigator&#xD;
&#xD;
          -  Patients who are not willing to give informed consent&#xD;
&#xD;
          -  Patients with a known history of hypersensitivity to betahistine&#xD;
&#xD;
          -  Patients with a history of pheochromocytoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raeefuddin Ahmed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research facility ID ORG-001139</name>
      <address>
        <city>Hyderabad</city>
        <zip>76090</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001053</name>
      <address>
        <city>Islamabad</city>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001070</name>
      <address>
        <city>Karachi</city>
        <zip>75050</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001051</name>
      <address>
        <city>Karachi</city>
        <zip>75190</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001069</name>
      <address>
        <city>Karachi</city>
        <zip>75900</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001050</name>
      <address>
        <city>Karachi</city>
        <zip>75950</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001060</name>
      <address>
        <city>Lahore</city>
        <zip>54570</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001054</name>
      <address>
        <city>Lahore</city>
        <zip>54660</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001055</name>
      <address>
        <city>Lahore</city>
        <zip>54660</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001061</name>
      <address>
        <city>Lahore</city>
        <zip>54810</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001052</name>
      <address>
        <city>Peshawar</city>
        <zip>7041298</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vertigo, Dizziness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_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/NCT02213120
org study id: BETA5003
nct id: NCT02213120
lead sponsor: 
collaborator: 
has dmc: No
The VERTIGO study is likely to help determine characteristics of different types of vertigo
      in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness.
      Moreover, it will also help to develop an understanding about the current management
      practices of this condition at local level.
observational model: Cohort
time perspective: Prospective
measure: Characteristics (Different Types) of dizziness
time frame: 6 months
description: It will be determined that a patient with dizziness is suffering from what type of Vertigo i.e. Benign Paroxysmal Positional Vertigo, Menier's Disease, Vestibular Neuritis, Labyrinthitis or any other. As these are clinical types of Vertigo these cannot be measured in units
measure: Quality of Life (QoL) of patients at baselines
time frame: 6 months
description: Dizziness Handicap Inventory will be used
measure: Management of vertigo currently in practice
time frame: 6 months
description: As per practice of the physician/Investigator. Management of Vertigo is either by certain maneuvers such as Epley's and Simont or by medications. For the maneuvers, no unit can be defined. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency.
measure: QoL of patients post treatment
time frame: 6 months
description: Dizziness Handicap Inventory will be used
arm group label: Dizziness
description: Patients with Dizziness
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raeefuddin Ahmed, MD
role: Study Director
affiliation: Abbott
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness