<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/NCT03255473</url>
  </required_header>
  <id_info>
    <org_study_id>16-2342</org_study_id>
    <nct_id>NCT03255473</nct_id>
  </id_info>
  <brief_title>High Dose Oral Steroids in Sudden Sensorineural Hearing Loss</brief_title>
  <official_title>High Dose Oral Steroids in Sudden Sensorineural Hearing Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare hearing outcomes between treatment with dexamethasone versus prednisone in&#xD;
      participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing&#xD;
      loss).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 per 100,000 persons&#xD;
      with spontaneous recovery seen in 32% to 65%. Many different treatments have been&#xD;
      investigated in attempt to improve hearing outcomes, with oral corticosteroids having some&#xD;
      success. Steroid regimens are highly variable, however, retrospective data has suggested&#xD;
      greater improvement in hearing outcomes with the use of high dose oral steroids&#xD;
      (dexamethasone) in the setting of unilateral sudden sensorineural hearing loss compared to&#xD;
      traditional medical therapy with lower dose oral prednisone. The investigators hypothesize&#xD;
      that patients with unilateral SSNHL who are randomized to treatment with high doses of oral&#xD;
      dexamethasone will show better hearing outcomes than patients who are randomized to the more&#xD;
      common standard clinical practice treatment with lower doses of oral prednisone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">March 13, 2023</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</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>
    <intervention_model_description>Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Hearing Threshold (Hearing Improvement)</measure>
    <time_frame>Baseline, 1 week, 1 month, 3 months</time_frame>
    <description>Pure tone averages (from pure tone audiometry) will be recorded for participants at each visit, and assessed for changes in pure tone average over time. Based on a change in pure tone average, participants will be categorized into the different groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Word Recognition Scores</measure>
    <time_frame>1 week, 1 month, 3 months, and assessed for change from baseline score.</time_frame>
    <description>Word recognition scores from speech audiometry tests will be summarized, by treatment arm, as a continuous variable using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pure Tone Averages</measure>
    <time_frame>1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..</time_frame>
    <description>Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Frequency Analysis Based on Hearing Improvement</measure>
    <time_frame>Baseline, 1 week, 1 month, 3 months</time_frame>
    <description>The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Percentage Analysis Based on Hearing Improvement</measure>
    <time_frame>Baseline, 1 week, 1 month, 3 months</time_frame>
    <description>The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Sudden Sensorineural Hearing Loss (SSNHL)</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subject identification (ID) numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prednisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <other_name>dexamethasone sodium phosphate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.</description>
    <arm_group_label>Prednisone</arm_group_label>
    <other_name>Deltasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 to 80 years old&#xD;
&#xD;
          -  Present to the Otology or Otolaryngology Clinic at the University of Colorado Hospital&#xD;
             with unilateral sudden sensorineural hearing loss (SSNHL)&#xD;
&#xD;
          -  Seen within six weeks of initial hearing loss&#xD;
&#xD;
          -  Unilateral hearing loss at screening as defined by:&#xD;
&#xD;
               -  Loss of 30 decibels (dB) HL or greater over 3 continuous frequencies with&#xD;
                  participants reporting that this hearing loss occurred within 3 days&#xD;
&#xD;
          -  Present with primary complaint of sensorineural hearing loss&#xD;
&#xD;
          -  Normal tympanometry (Type A)&#xD;
&#xD;
          -  Normal tympanic membrane&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants for whom high dose corticosteroids are a contraindicated due to:&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Known allergies to corticosteroids&#xD;
&#xD;
               -  Other concurrent medical conditions and or medications where high dose oral&#xD;
                  corticosteroids are not safe to use&#xD;
&#xD;
          -  Participants who have Type 1 or Type 2 diabetes&#xD;
&#xD;
          -  Participants who have previously received a course of oral steroids for this&#xD;
             indication&#xD;
&#xD;
          -  Participants who have bilateral SSNHL&#xD;
&#xD;
          -  Participants with conductive hearing loss, mixed hearing loss (sensorineural and&#xD;
             conductive), or any type of hearing loss that is not SSNHL (i.e. caused by acoustic or&#xD;
             physical trauma to the ear)&#xD;
&#xD;
          -  Participants with the following conditions/situations will be excluded because the&#xD;
             possibility that these could cause SSNHL:&#xD;
&#xD;
               -  History of previous/recurrent unilateral SSNHL&#xD;
&#xD;
               -  History of fluctuating hearing in either ear&#xD;
&#xD;
               -  History of Meniere's syndrome&#xD;
&#xD;
               -  History of chronic granulomatous or suppurative otitis media or cholesteatoma in&#xD;
                  either ear&#xD;
&#xD;
               -  History of otosclerosis in either ear&#xD;
&#xD;
          -  Participants with the following conditions/situations will be excluded due to risk of&#xD;
             misclassification of diagnosis of idiopathic SSNHL or because these participants are&#xD;
             at higher risk for potential steroid side effects due to other comorbidities. If the&#xD;
             time line is not otherwise stated, then the participant will be excluded if they&#xD;
             experienced these criteria at any point in their lifetime:&#xD;
&#xD;
               -  Received oral steroids (for any indication besides SSNHL) for greater than 21&#xD;
                  days in the preceding 30 days&#xD;
&#xD;
               -  Systemic fungal infections in the last 6 months&#xD;
&#xD;
               -  History of tuberculosis or history of prophylactic tuberculosis treatment for&#xD;
                  positive skin test (PPD)&#xD;
&#xD;
               -  History of unstable angina, coronary artery stenting or bypass graft within 3&#xD;
                  months&#xD;
&#xD;
               -  History of transient ischemic attacks, cardiac arrhythmia, or stroke in the last&#xD;
                  4 weeks&#xD;
&#xD;
               -  Serious psychiatric disease or history of psychiatric reaction to&#xD;
                  corticosteroids, specifically bipolar, schizophrenia, episodes of mania or&#xD;
                  delirium&#xD;
&#xD;
               -  Prior treatment with chemotherapy agents, immunosuppressive drugs, cyclosporine,&#xD;
                  or interferon&#xD;
&#xD;
               -  Pancreatitis in the last year&#xD;
&#xD;
               -  Active peptic ulcer disease or history of gastrointestinal bleeding in the last&#xD;
                  year&#xD;
&#xD;
               -  History of known HIV, hepatitis C, or hepatitis B infection&#xD;
&#xD;
               -  Chronic renal insufficiency requiring dialysis&#xD;
&#xD;
               -  Active shingles (herpes zoster infection)&#xD;
&#xD;
               -  Advanced/severe osteoporosis or nonsurgical aseptic necrosis of the hip&#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>Stephen P Cass, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</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>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Dexamethasone 21-phosphate</mesh_term>
    <mesh_term>BB 1101</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/NCT03255473
org study id: 16-2342
nct id: NCT03255473
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Compare hearing outcomes between treatment with dexamethasone versus prednisone in
      participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing
      loss).
Sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 per 100,000 persons
      with spontaneous recovery seen in 32% to 65%. Many different treatments have been
      investigated in attempt to improve hearing outcomes, with oral corticosteroids having some
      success. Steroid regimens are highly variable, however, retrospective data has suggested
      greater improvement in hearing outcomes with the use of high dose oral steroids
      (dexamethasone) in the setting of unilateral sudden sensorineural hearing loss compared to
      traditional medical therapy with lower dose oral prednisone. The investigators hypothesize
      that patients with unilateral SSNHL who are randomized to treatment with high doses of oral
      dexamethasone will show better hearing outcomes than patients who are randomized to the more
      common standard clinical practice treatment with lower doses of oral prednisone.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Hearing Threshold (Hearing Improvement)
time frame: Baseline, 1 week, 1 month, 3 months
description: Pure tone averages (from pure tone audiometry) will be recorded for participants at each visit, and assessed for changes in pure tone average over time. Based on a change in pure tone average, participants will be categorized into the different groups.
measure: Changes in Word Recognition Scores
time frame: 1 week, 1 month, 3 months, and assessed for change from baseline score.
description: Word recognition scores from speech audiometry tests will be summarized, by treatment arm, as a continuous variable using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
measure: Changes in Pure Tone Averages
time frame: 1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..
description: Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.
measure: Clinical Frequency Analysis Based on Hearing Improvement
time frame: Baseline, 1 week, 1 month, 3 months
description: The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
measure: Clinical Percentage Analysis Based on Hearing Improvement
time frame: Baseline, 1 week, 1 month, 3 months
description: The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
arm group label: Dexamethasone
arm group type: Active Comparator
description: All subject identification (ID) numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
arm group label: Prednisone
arm group type: Active Comparator
description: All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
intervention type: Drug
intervention name: Dexamethasone
description: All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
arm group label: Dexamethasone
other name: dexamethasone sodium phosphate
intervention type: Drug
intervention name: Prednisone
description: All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
arm group label: Prednisone
other name: Deltasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Stephen P Cass, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Prednisone
mesh term: Dexamethasone 21-phosphate
mesh term: BB 1101
sharing ipd: No