<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/NCT03818815</url>
  </required_header>
  <id_info>
    <org_study_id>OP0201-C-006</org_study_id>
    <nct_id>NCT03818815</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months</brief_title>
  <official_title>A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novus Therapeutics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novus Therapeutics, Inc</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop a better understanding of the safety, tolerability&#xD;
      and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the&#xD;
      treatment of Acute Otitis Media (AOM) in infants and children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Days 1-28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Efficacy (Otoscopy)</measure>
    <time_frame>Day 4</time_frame>
    <description>Percentage of study participants with no bulging tympanic membrane</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Efficacy (Otoscopy)</measure>
    <time_frame>Day 12</time_frame>
    <description>Percentage of study participants with no middle ear effusion</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Acute Otitis Media</condition>
  <arm_group>
    <arm_group_label>Drug: OP0201 + Antibiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator: Placebo +Antibiotics</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>OP0201</intervention_name>
    <description>OP0201 20mg per day in two divided doses for 10 days</description>
    <arm_group_label>Drug: OP0201 + Antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 0mg per day in two divided doses for 10 days</description>
    <arm_group_label>Placebo Comparator: Placebo +Antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin-clavulanate</intervention_name>
    <description>Oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
    <arm_group_label>Drug: OP0201 + Antibiotics</arm_group_label>
    <arm_group_label>Placebo Comparator: Placebo +Antibiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria includes but is not limited to:&#xD;
&#xD;
          1. Male and female infants and children aged ≥6 months to ≤24 months&#xD;
&#xD;
          2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild&#xD;
             bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of&#xD;
             the TM&#xD;
&#xD;
          3. Score of 5 or more on the 5 question version of AOM-SOS scale1&#xD;
&#xD;
          4. Written informed consent by the child's legal guardian and their willingness to ensure&#xD;
             that study instructions are followed, all study-related visits are attended, that&#xD;
             treatment administration is given, and Parent/Caregiver assessments are recorded&#xD;
             according to the study protocol.&#xD;
&#xD;
          5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)&#xD;
&#xD;
        Exclusion Criteria includes but is not limited to:&#xD;
&#xD;
          1. Allergy to penicillin or cephalosporin&#xD;
&#xD;
          2. History or presence of immunodeficiency disorders&#xD;
&#xD;
          3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1&#xD;
&#xD;
          4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere&#xD;
             with Eustachian tube function&#xD;
&#xD;
          5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous&#xD;
             (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)&#xD;
&#xD;
          6. Clinically relevant blockage of 1 or both nasal passages, as determined by the&#xD;
             investigator's medical judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novustherapeutics.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>July 1, 2020</results_first_submitted>
  <results_first_submitted_qc>July 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2020</results_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</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>Otitis</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03818815/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03818815/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: OP0201 + Antibiotics</title>
          <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days&#xD;
OP0201 20mg per day+Amoxicillin-clavulanate: OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
        <group group_id="P2">
          <title>Placebo Comparator: Placebo +Antibiotics</title>
          <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days&#xD;
Placebo 0mg per day+Amoxicillin-clavulanate: Placebo 0mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug: OP0201 + Antibiotics</title>
          <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
        <group group_id="B2">
          <title>Placebo Comparator: Placebo + Antibiotics</title>
          <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="103"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.4" spread="4.70"/>
                    <measurement group_id="B2" value="13.2" spread="5.01"/>
                    <measurement group_id="B3" value="13.3" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <time_frame>Days 1-28</time_frame>
        <population>Subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 + Antibiotics</title>
            <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo Comparator: Placebo + Antibiotics</title>
            <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <population>Subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Efficacy (Otoscopy)</title>
        <description>Percentage of study participants with no bulging tympanic membrane</description>
        <time_frame>Day 4</time_frame>
        <population>Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 + Antibiotics</title>
            <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo Comparator: Placebo + Antibiotics</title>
            <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Efficacy (Otoscopy)</title>
          <description>Percentage of study participants with no bulging tympanic membrane</description>
          <population>Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The summary statistics are based on subjects with non-missing data only.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.62</p_value>
            <p_value_desc>The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Efficacy (Otoscopy)</title>
        <description>Percentage of study participants with no middle ear effusion</description>
        <time_frame>Day 12</time_frame>
        <population>Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: OP0201 + Antibiotics</title>
            <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo Comparator: Placebo + Antibiotics</title>
            <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Efficacy (Otoscopy)</title>
          <description>Percentage of study participants with no middle ear effusion</description>
          <population>Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9"/>
                    <measurement group_id="O2" value="37.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The summary statistics are based on subjects with non-missing data only.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <p_value_desc>The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <desc>The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.</desc>
      <group_list>
        <group group_id="E1">
          <title>Drug: OP0201 + Antibiotics</title>
          <description>OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
        <group group_id="E2">
          <title>Placebo Comparator: Placebo + Antibiotics</title>
          <description>Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>KAWASAKIS DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="55"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Nasal Discharge Discolouration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="55"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Diaper</sub_title>
                <counts group_id="E1" events="39" subjects_affected="33" subjects_at_risk="55"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Director</name_or_title>
      <organization>Novus Therapeutics</organization>
      <phone>949-679-1110</phone>
      <email>study006@novustherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03818815
org study id: OP0201-C-006
nct id: NCT03818815
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to develop a better understanding of the safety, tolerability
      and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the
      treatment of Acute Otitis Media (AOM) in infants and children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants With Adverse Events
time frame: Days 1-28
measure: Evaluation of Efficacy (Otoscopy)
time frame: Day 4
description: Percentage of study participants with no bulging tympanic membrane
measure: Evaluation of Efficacy (Otoscopy)
time frame: Day 12
description: Percentage of study participants with no middle ear effusion
arm group label: Drug: OP0201 + Antibiotics
arm group type: Active Comparator
description: OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
arm group label: Placebo Comparator: Placebo +Antibiotics
arm group type: Placebo Comparator
description: Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
intervention type: Combination Product
intervention name: OP0201
description: OP0201 20mg per day in two divided doses for 10 days
arm group label: Drug: OP0201 + Antibiotics
intervention type: Combination Product
intervention name: Placebo
description: Placebo 0mg per day in two divided doses for 10 days
arm group label: Placebo Comparator: Placebo +Antibiotics
intervention type: Drug
intervention name: Amoxicillin-clavulanate
description: Oral Amoxicillin-clavulanate in two divided doses for 10 days
arm group label: Drug: OP0201 + Antibiotics
arm group label: Placebo Comparator: Placebo +Antibiotics
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: No
facility: 
country: United States
url: http://novustherapeutics.com/
description: Related Info
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Media
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 