<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/NCT01678807</url>
  </required_header>
  <id_info>
    <org_study_id>8237-008</org_study_id>
    <secondary_id>MK-8237-008</secondary_id>
    <nct_id>NCT01678807</nct_id>
  </id_info>
  <brief_title>Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)</brief_title>
  <official_title>Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ALK-Abelló A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ALK-Abelló A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]&#xD;
      and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust&#xD;
      mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least&#xD;
      one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house&#xD;
      dust mite-induced allergic rhinitis/rhinoconjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 1</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Experienced At Least One Adverse Event (AE)</measure>
    <time_frame>From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</measure>
    <time_frame>From first dose to last dose of treatment, up to 28 days</time_frame>
    <description>The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">195</enrollment>
  <condition>Rhinitis, Allergic, Perennial</condition>
  <condition>Rhinitis, Allergic, Nonseasonal</condition>
  <arm_group>
    <arm_group_label>MK-8237 6 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MK-8237 12 DU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo rapidly dissolving tablet administered sublingually once daily for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MK-8237 6 DU</intervention_name>
    <arm_group_label>MK-8237 6 DU</arm_group_label>
    <other_name>SCH 900237</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MK-8237 12 DU</intervention_name>
    <arm_group_label>MK-8237 12 DU</arm_group_label>
    <other_name>SCH 900237</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of&#xD;
             at least 6 months duration (with or without asthma)&#xD;
&#xD;
          -  History of controlled asthma for the prior 1 month if participant has asthma, defined&#xD;
             by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short&#xD;
             acting beta-agonist [SABA] use per week; and not wakening more than twice a month at&#xD;
             night due to asthma symptoms&#xD;
&#xD;
          -  Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of&#xD;
             birth control from screening and through the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to meet medication washout requirements&#xD;
&#xD;
          -  History of chronic urticaria and/or chronic angioedema within prior 2 years&#xD;
&#xD;
          -  History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to&#xD;
             an unknown cause or to an inhalant allergen&#xD;
&#xD;
          -  Unstable, uncontrolled or severe asthma, or has experienced a life-threatening asthma&#xD;
             attack or an occurrence of any clinical deterioration of asthma that resulted in&#xD;
             emergency treatment, hospitalization due to asthma, or treatment with systemic&#xD;
             corticosteroids (but allowing SABAs) at any time within prior 3 months&#xD;
&#xD;
          -  History of chronic sinusitis during within prior 2 years&#xD;
&#xD;
          -  Pregnant or breast-feeding, or expecting to conceive within the projected duration of&#xD;
             the study&#xD;
&#xD;
          -  Known history of allergy, hypersensitivity or intolerance to investigational medicinal&#xD;
             products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or&#xD;
             Dermatophagoides farina (D. farina) or self-injectable epinephrine&#xD;
&#xD;
          -  Business or personal relationship with investigational site personnel or Sponsor who&#xD;
             is directly involved with the conduct of the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59-65. doi: 10.1016/j.anai.2015.10.024. Epub 2015 Nov 6.</citation>
    <PMID>26553448</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>December 20, 2016</results_first_submitted>
  <results_first_submitted_qc>December 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2017</results_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 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>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Perennial</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 6 months duration or more and had a positive skin prick test response to Dermatophagoides pteronyssinus or Dermatophagoides farina at the screening visit. Other inclusion and exclusion criteria applied.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>MK-8237 12 Development Units (DU)</title>
          <description>Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days</description>
        </group>
        <group group_id="P2">
          <title>MK-8237 6 DU</title>
          <description>Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 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="65"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MK-8237 12 DU</title>
          <description>Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days</description>
        </group>
        <group group_id="B2">
          <title>MK-8237 6 DU</title>
          <description>Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days</description>
        </group>
        <group group_id="B4">
          <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="65"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="65"/>
            <count group_id="B4" value="195"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.5" spread="1.6"/>
                    <measurement group_id="B2" value="14.5" spread="1.7"/>
                    <measurement group_id="B3" value="14.3" spread="1.8"/>
                    <measurement group_id="B4" value="14.4" spread="1.7"/>
                  </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="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experienced At Least One Adverse Event (AE)</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.</description>
        <time_frame>From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days</time_frame>
        <population>All randomized participants who receive at least one dose of study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237 12 DU</title>
            <description>Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days</description>
          </group>
          <group group_id="O2">
            <title>MK-8237 6 DU</title>
            <description>Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced At Least One Adverse Event (AE)</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.</description>
          <population>All randomized participants who receive at least one dose of study treatment</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="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.9"/>
                    <measurement group_id="O2" value="53.8"/>
                    <measurement group_id="O3" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Percent Difference</param_type>
            <param_value>13.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4</ci_lower_limit>
            <ci_upper_limit>30.3</ci_upper_limit>
            <estimate_desc>Estimate based on Miettinen &amp; Nurminen method stratified by asthma status.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Percent Difference</param_type>
            <param_value>10.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.4</ci_lower_limit>
            <ci_upper_limit>27.4</ci_upper_limit>
            <estimate_desc>Estimate based on Miettinen &amp; Nurminen method stratified by asthma status.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
        <description>The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.</description>
        <time_frame>From first dose to last dose of treatment, up to 28 days</time_frame>
        <population>All randomized participants who receive at least one dose of study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237 12 DU</title>
            <description>Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days</description>
          </group>
          <group group_id="O2">
            <title>MK-8237 6 DU</title>
            <description>Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event</title>
          <description>The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.</description>
          <population>All randomized participants who receive at least one dose of study treatment</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="65"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                    <measurement group_id="O2" value="6.2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Percent Difference</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>14.8</ci_upper_limit>
            <estimate_desc>Estimate based on Miettinen &amp; Nurminen method stratified by asthma status.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Percent Difference</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>14.8</ci_upper_limit>
            <estimate_desc>Estimate based on Miettinen &amp; Nurminen method stratified by asthma status.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days</time_frame>
      <desc>Adverse events for all randomized participants who receive at least one dose of study treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>MK-8237 12 DU</title>
          <description>Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days</description>
        </group>
        <group group_id="E2">
          <title>MK-8237 6 DU</title>
          <description>Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <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="29" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="22" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" events="31" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E2" events="40" subjects_affected="11" subjects_at_risk="65"/>
                <counts group_id="E3" events="11" subjects_affected="5" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="13" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Tongue pruritus</sub_title>
                <counts group_id="E1" events="14" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E2" events="19" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </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="1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="36" subjects_affected="13" subjects_at_risk="65"/>
                <counts group_id="E2" events="24" subjects_affected="12" subjects_at_risk="65"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </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>The Sponsor has the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01678807
org study id: 8237-008
secondary id: MK-8237-008
nct id: NCT01678807
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]
      and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust
      mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least
      one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house
      dust mite-induced allergic rhinitis/rhinoconjunctivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Who Experienced At Least One Adverse Event (AE)
time frame: From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
time frame: From first dose to last dose of treatment, up to 28 days
description: The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
arm group label: MK-8237 6 DU
arm group type: Experimental
description: MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
arm group label: MK-8237 12 DU
arm group type: Experimental
description: MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo rapidly dissolving tablet administered sublingually once daily for 28 days
intervention type: Biological
intervention name: MK-8237 6 DU
arm group label: MK-8237 6 DU
other name: SCH 900237
intervention type: Biological
intervention name: MK-8237 12 DU
arm group label: MK-8237 12 DU
other name: SCH 900237
intervention type: Biological
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: United States
citation: Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59-65. doi: 10.1016/j.anai.2015.10.024. Epub 2015 Nov 6.
PMID: 26553448
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 