<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/NCT01700192</url>
  </required_header>
  <id_info>
    <org_study_id>P05607</org_study_id>
    <secondary_id>MK-8237-001</secondary_id>
    <nct_id>NCT01700192</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)</brief_title>
  <official_title>A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the&#xD;
      treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in&#xD;
      children and adults.&#xD;
&#xD;
      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,&#xD;
      results in significant reduction in the average total combined rhinitis score (TCRS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 3</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>Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment</measure>
    <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
    <description>The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experience At Least One Adverse Event (AE)</measure>
    <time_frame>Up to 54 weeks</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Discontinue Study Drug Due to an AE</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment</measure>
    <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
    <description>The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment</measure>
    <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
    <description>The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment</measure>
    <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
    <description>The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment</measure>
    <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
    <description>Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (&quot;no symptoms&quot;) to 100 (&quot;severe symptoms&quot;). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1482</enrollment>
  <condition>Rhinitis, Allergic, Perennial</condition>
  <condition>Rhinitis, Allergic, Nonseasonal</condition>
  <arm_group>
    <arm_group_label>MK-8237</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MK-8237 tablets</intervention_name>
    <description>MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.</description>
    <arm_group_label>MK-8237</arm_group_label>
    <other_name>SCH 900237</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo tablets</intervention_name>
    <description>Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue Medication: Self-Injectable Epinephrine</intervention_name>
    <description>Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.</description>
    <arm_group_label>MK-8237</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue Medication: Loratadine tablets</intervention_name>
    <description>Loratadine tablet 10 mg administered orally as needed for rescue medication.</description>
    <arm_group_label>MK-8237</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue Medication: Olopatadine ophthalmic drops</intervention_name>
    <description>Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.</description>
    <arm_group_label>MK-8237</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue Medication: Mometasone furoate nasal spray</intervention_name>
    <description>Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.</description>
    <arm_group_label>MK-8237</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of AR/ARC to house dust of 1 year duration or more (with or without asthma)&#xD;
&#xD;
          -  If female of childbearing potential, has a negative urine pregnancy test at Screening&#xD;
             and agrees to remain abstinent or use (or have their partner use) an acceptable method&#xD;
             of birth control within the projected duration of the study&#xD;
&#xD;
          -  Able to read, understand and complete questionnaires and diaries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or&#xD;
             cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen&#xD;
&#xD;
          -  History of symptomatic seasonal ARC and/or asthma due to an allergen to which the&#xD;
             participant is sensitized and regularly exposed&#xD;
&#xD;
          -  Nasal condition that could confound the efficacy or safety assessments (e.g., nasal&#xD;
             polyposis)&#xD;
&#xD;
          -  Received an immunosuppressive treatment within 3 months prior to screening&#xD;
&#xD;
          -  Unstable or severe asthma, or has experienced a life-threatening asthma attack or an&#xD;
             occurrence of any clinical deterioration of asthma that resulted in emergency&#xD;
             treatment, hospitalization due to asthma, or treatment with systemic corticosteroids&#xD;
             (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to&#xD;
             screening&#xD;
&#xD;
          -  History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,&#xD;
             unknown cause or inhalant allergen&#xD;
&#xD;
          -  History of chronic urticaria and/or angioedema within 2 years prior to screening&#xD;
&#xD;
          -  History of chronic sinusitis during 2 years prior to screening&#xD;
&#xD;
          -  Pregnant, breastfeeding, or expecting to conceive within the projected duration of the&#xD;
             study&#xD;
&#xD;
          -  Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5&#xD;
             years prior to screening&#xD;
&#xD;
          -  Previous exposure to MK-8237&#xD;
&#xD;
          -  Receiving ongoing treatment with any specific immunotherapy at screening&#xD;
&#xD;
          -  Known history of allergy, hypersensitivity or intolerance to investigational medicinal&#xD;
             products (except for D. pteronyssinus and/or D. farinae), rescue medications or&#xD;
             self-injectable epinephrine&#xD;
&#xD;
          -  Unable to meet medication washout requirements prior to screening&#xD;
&#xD;
          -  Unable or unwilling to comply with the use of 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 study&#xD;
&#xD;
          -  Likely to travel for extended periods of time during the efficacy assessment period&#xD;
&#xD;
          -  Participating in a different investigational study at any site during this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</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>Canada</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.</citation>
    <PMID>27521719</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>January 11, 2017</results_first_submitted>
  <results_first_submitted_qc>January 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
    <mesh_term>Loratadine</mesh_term>
    <mesh_term>Olopatadine Hydrochloride</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MK-8237</title>
          <description>Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="741"/>
                <participants group_id="P2" count="741"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="740"/>
                <participants group_id="P2" count="741"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Participants as Treated (APaT)</title>
              <participants_list>
                <participants group_id="P1" count="743">Three participants randomized to receive placebo were given MK-8237 12 DU.</participants>
                <participants group_id="P2" count="738">Three participants randomized to receive placebo were given MK-8237 12 DU.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="561"/>
                <participants group_id="P2" count="613"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical problems</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Never received study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristics refer to all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>MK-8237</title>
          <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</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="741"/>
            <count group_id="B2" value="741"/>
            <count group_id="B3" value="1482"/>
          </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="34.9" spread="13.82" lower_limit="12" upper_limit="77"/>
                    <measurement group_id="B2" value="35.2" spread="13.74" lower_limit="12" upper_limit="85"/>
                    <measurement group_id="B3" value="35.1" spread="13.77" lower_limit="12" upper_limit="85"/>
                  </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="445"/>
                    <measurement group_id="B2" value="430"/>
                    <measurement group_id="B3" value="875"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="296"/>
                    <measurement group_id="B2" value="311"/>
                    <measurement group_id="B3" value="607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment</title>
        <description>The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
        <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
        <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment</title>
          <description>The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
          <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="566"/>
                <count group_id="O2" value="620"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="3.55"/>
                    <measurement group_id="O2" value="5.49" spread="3.82"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.20</ci_lower_limit>
            <ci_upper_limit>-0.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Treatment Difference Relative to Placebo</param_type>
            <param_value>-17.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.0</ci_lower_limit>
            <ci_upper_limit>-9.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experience At Least One Adverse Event (AE)</title>
        <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to 54 weeks</time_frame>
        <population>The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experience At Least One Adverse Event (AE)</title>
          <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="743"/>
                <count group_id="O2" value="738"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="676"/>
                    <measurement group_id="O2" value="539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Discontinue Study Drug Due to an AE</title>
        <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinue Study Drug Due to an AE</title>
          <description>An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="743"/>
                <count group_id="O2" value="738"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment</title>
        <description>The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
        <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
        <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment</title>
          <description>The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
          <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="566"/>
                <count group_id="O2" value="620"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.83" spread="2.64"/>
                    <measurement group_id="O2" value="4.46" spread="2.80"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.00</ci_lower_limit>
            <ci_upper_limit>-0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Treatment Difference Relative to Placebo</param_type>
            <param_value>-15.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.4</ci_lower_limit>
            <ci_upper_limit>-7.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment</title>
        <description>The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
        <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
        <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment</title>
          <description>The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
          <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="566"/>
                <count group_id="O2" value="620"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="1.817"/>
                    <measurement group_id="O2" value="1.03" spread="2.074"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.154</p_value>
            <method>Zero-inflated Log-normal Model</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Treatment Difference Relative to Placebo</param_type>
            <param_value>-18.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41</ci_lower_limit>
            <ci_upper_limit>4.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment</title>
        <description>The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
        <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
        <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment</title>
          <description>The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.</description>
          <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="566"/>
                <count group_id="O2" value="620"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.40" spread="5.16"/>
                    <measurement group_id="O2" value="7.62" spread="5.48"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.70</ci_lower_limit>
            <ci_upper_limit>-0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Treatment Difference Relative to Placebo</param_type>
            <param_value>-16.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.6</ci_lower_limit>
            <ci_upper_limit>-4.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment</title>
        <description>Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (&quot;no symptoms&quot;) to 100 (&quot;severe symptoms&quot;). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).</description>
        <time_frame>Last 8 weeks of treatment (Weeks 44 to 52)</time_frame>
        <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
        <group_list>
          <group group_id="O1">
            <title>MK-8237</title>
            <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment</title>
          <description>Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (&quot;no symptoms&quot;) to 100 (&quot;severe symptoms&quot;). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).</description>
          <population>The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="540"/>
                <count group_id="O2" value="585"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.29" spread="23.57"/>
                    <measurement group_id="O2" value="47.96" spread="23.66"/>
                  </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>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-6.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.10</ci_lower_limit>
            <ci_upper_limit>-3.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Treatment Difference Relative to Placebo</param_type>
            <param_value>-16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.7</ci_lower_limit>
            <ci_upper_limit>-8.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 54 weeks</time_frame>
      <desc>The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).</desc>
      <group_list>
        <group group_id="E1">
          <title>MK-8237 12 DU</title>
          <description>Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="743"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oral pain</sub_title>
                <description>Due to overdose; classified as SAE by sponsor but does not meet International Council for Harmonisation (ICH) SAE criteria.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <description>Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Infected bites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="743"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title vocab="MedDRA v. 18.0">Alcohol abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus ureteric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Throat irritation</sub_title>
                <description>Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="743"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="642" subjects_at_risk="743"/>
                <counts group_id="E2" subjects_affected="389" subjects_at_risk="738"/>
              </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="1637" subjects_affected="382" subjects_at_risk="743"/>
                <counts group_id="E2" events="244" subjects_affected="92" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="212" subjects_affected="92" subjects_at_risk="743"/>
                <counts group_id="E2" events="87" subjects_affected="44" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="85" subjects_affected="55" subjects_at_risk="743"/>
                <counts group_id="E2" events="42" subjects_affected="27" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="296" subjects_affected="119" subjects_at_risk="743"/>
                <counts group_id="E2" events="58" subjects_affected="26" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="353" subjects_affected="140" subjects_at_risk="743"/>
                <counts group_id="E2" events="42" subjects_affected="19" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Mouth swelling</sub_title>
                <counts group_id="E1" events="165" subjects_affected="73" subjects_at_risk="743"/>
                <counts group_id="E2" events="32" subjects_affected="12" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="196" subjects_affected="85" subjects_at_risk="743"/>
                <counts group_id="E2" events="41" subjects_affected="27" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="293" subjects_affected="121" subjects_at_risk="743"/>
                <counts group_id="E2" events="111" subjects_affected="57" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" events="1966" subjects_affected="468" subjects_at_risk="743"/>
                <counts group_id="E2" events="277" subjects_affected="109" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Palatal swelling</sub_title>
                <counts group_id="E1" events="183" subjects_affected="82" subjects_at_risk="743"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="173" subjects_affected="71" subjects_at_risk="743"/>
                <counts group_id="E2" events="28" subjects_affected="21" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" events="255" subjects_affected="123" subjects_at_risk="743"/>
                <counts group_id="E2" events="31" subjects_affected="17" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" events="232" subjects_affected="96" subjects_at_risk="743"/>
                <counts group_id="E2" events="29" subjects_affected="21" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="81" subjects_affected="62" subjects_at_risk="743"/>
                <counts group_id="E2" events="68" subjects_affected="61" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="76" subjects_affected="63" subjects_at_risk="743"/>
                <counts group_id="E2" events="87" subjects_affected="74" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="143" subjects_affected="73" subjects_at_risk="743"/>
                <counts group_id="E2" events="48" subjects_affected="29" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="43" subjects_affected="35" subjects_at_risk="743"/>
                <counts group_id="E2" events="63" subjects_affected="47" subjects_at_risk="738"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" events="268" subjects_affected="109" subjects_at_risk="743"/>
                <counts group_id="E2" events="40" subjects_affected="23" subjects_at_risk="738"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="2144" subjects_affected="506" subjects_at_risk="743"/>
                <counts group_id="E2" events="505" subjects_affected="172" subjects_at_risk="738"/>
              </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 must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Corporate 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/NCT01700192
org study id: P05607
secondary id: MK-8237-001
nct id: NCT01700192
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the
      treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in
      children and adults.

      The primary hypothesis of this study is that administration of MK-8237, compared to placebo,
      results in significant reduction in the average total combined rhinitis score (TCRS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
time frame: Last 8 weeks of treatment (Weeks 44 to 52)
description: The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
measure: Number of Participants Who Experience At Least One Adverse Event (AE)
time frame: Up to 54 weeks
description: An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Number of Participants Who Discontinue Study Drug Due to an AE
time frame: Up to 52 weeks
description: An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
time frame: Last 8 weeks of treatment (Weeks 44 to 52)
description: The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
measure: Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
time frame: Last 8 weeks of treatment (Weeks 44 to 52)
description: The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
measure: Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
time frame: Last 8 weeks of treatment (Weeks 44 to 52)
description: The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
measure: Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
time frame: Last 8 weeks of treatment (Weeks 44 to 52)
description: Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
arm group label: MK-8237
arm group type: Experimental
description: MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
intervention type: Biological
intervention name: MK-8237 tablets
description: MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
arm group label: MK-8237
other name: SCH 900237
intervention type: Biological
intervention name: Placebo tablets
description: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
arm group label: Placebo
intervention type: Drug
intervention name: Rescue Medication: Self-Injectable Epinephrine
description: Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
arm group label: MK-8237
arm group label: Placebo
intervention type: Drug
intervention name: Rescue Medication: Loratadine tablets
description: Loratadine tablet 10 mg administered orally as needed for rescue medication.
arm group label: MK-8237
arm group label: Placebo
intervention type: Drug
intervention name: Rescue Medication: Olopatadine ophthalmic drops
description: Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
arm group label: MK-8237
arm group label: Placebo
intervention type: Drug
intervention name: Rescue Medication: Mometasone furoate nasal spray
description: Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
arm group label: MK-8237
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Canada
country: United States
citation: Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.
PMID: 27521719
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
mesh term: Mometasone Furoate
mesh term: Loratadine
mesh term: Olopatadine Hydrochloride
mesh term: Epinephrine
mesh term: Ophthalmic Solutions
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 