<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/NCT02265393</url>
  </required_header>
  <id_info>
    <org_study_id>104-201403</org_study_id>
    <nct_id>NCT02265393</nct_id>
  </id_info>
  <brief_title>A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom</brief_title>
  <official_title>A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otonomy, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otonomy, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United&#xD;
      Kingdom. The first part is a randomized, placebo-controlled study comparing the safety&#xD;
      profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an&#xD;
      open-label extension where all subjects will receive an additional 2 intratympanic injections&#xD;
      of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1&#xD;
      year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>Up to 1 Year</time_frame>
    <description>Otoscopy, audiometry, tympanometry, adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Meniere's Symptom Questionnaire</measure>
    <time_frame>Up to 1 Year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Meniere's Disease</condition>
  <arm_group>
    <arm_group_label>OTO-104</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 mg OTO-104 (dexamethasone)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>OTO-104 vehicle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTO-104</intervention_name>
    <arm_group_label>OTO-104</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria includes, but is not limited to:&#xD;
&#xD;
          -  Subject has a diagnosis of definite unilateral Meniere's disease.&#xD;
&#xD;
          -  Subject agrees to maintain their current standard of care treatments for Meniere's&#xD;
             disease while on-study.&#xD;
&#xD;
        Exclusion Criteria includes, but is not limited to:&#xD;
&#xD;
          -  Subject is pregnant or lactating.&#xD;
&#xD;
          -  Subject has a history of immunodeficiency disease.&#xD;
&#xD;
          -  Subject has a history of previous endolymphatic sac surgery.&#xD;
&#xD;
          -  Subject has a history of previous use of intratympanic gentamicin in the affected ear.&#xD;
&#xD;
          -  Subject has a history of drop attacks.&#xD;
&#xD;
          -  Subject has experienced an adverse reaction to intratympanic injection of steroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carl LeBel, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Otonomy, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heatherwood &amp; Wexham Park Hospitals</name>
      <address>
        <city>Berkshire</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham University Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BMI The Edgbaston Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital Bristol</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals</name>
      <address>
        <city>Bucks</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorset County Hospital</name>
      <address>
        <city>Dorset</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hospital</name>
      <address>
        <city>Gloucester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicestershire</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital and St. Thomas' Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk &amp; Norwich University Hospital</name>
      <address>
        <city>Norfolk</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals &amp; Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital</name>
      <address>
        <city>Staffordshire</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <disposition_first_submitted>August 16, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>August 16, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 18, 2017</disposition_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meniere Disease</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 25, 2022</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02265393
org study id: 104-201403
nct id: NCT02265393
lead sponsor: 
has dmc: Yes
This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United
      Kingdom. The first part is a randomized, placebo-controlled study comparing the safety
      profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an
      open-label extension where all subjects will receive an additional 2 intratympanic injections
      of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1
      year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Safety
time frame: Up to 1 Year
description: Otoscopy, audiometry, tympanometry, adverse events
measure: Meniere's Symptom Questionnaire
time frame: Up to 1 Year
arm group label: OTO-104
arm group type: Active Comparator
description: 12 mg OTO-104 (dexamethasone)
arm group label: Placebo
arm group type: Placebo Comparator
description: OTO-104 vehicle
intervention type: Drug
intervention name: OTO-104
arm group label: OTO-104
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carl LeBel, PhD
role: Study Chair
affiliation: Otonomy, Inc.
facility: 
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country: United Kingdom
responsible party type: Sponsor
mesh term: Meniere Disease
submitted: October 25, 2022