<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/NCT01673620</url>
  </required_header>
  <id_info>
    <org_study_id>0476A-484</org_study_id>
    <nct_id>NCT01673620</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of montelukast 10&#xD;
      mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2012</start_date>
  <completion_date type="Actual">October 10, 2012</completion_date>
  <primary_completion_date type="Actual">October 10, 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing at Least One Adverse Event (AE)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Discontinuing Study Treatment Due to AEs</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Montelukast 10 mg/loratadine 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo tablet administered orally once daily for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast 10 mg/loratadine 10 mg</intervention_name>
    <description>Montelukast 10 mg/loratadine 10 mg tablet administered once daily</description>
    <arm_group_label>Montelukast 10 mg/loratadine 10 mg</arm_group_label>
    <other_name>MK-0476A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo tablet administered once daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not pregnant or breastfeeding and does not plan to become pregnant during the study&#xD;
             and the 14-day follow-up period&#xD;
&#xD;
          -  Female participants of reproductive potential agree to remain abstinent or use one&#xD;
             acceptable method of birth control at least 14 days prior to signing the informed&#xD;
             consent until 14 days following the last visit&#xD;
&#xD;
          -  History for at least 2 years of seasonal allergic rhinitis symptoms that are known to&#xD;
             flare during the local allergy season or a clinical history of at least 2 years of&#xD;
             perennial allergic rhinitis symptoms that persist year round&#xD;
&#xD;
          -  For participants with seasonal allergic rhinitis: a positive skin-prick test (wheal &gt;=&#xD;
             3 mm greater than saline control) to one of the allergens active during the local&#xD;
             allergy season or a positive radioallergosorbent test (RAST [defined as a score &gt;=&#xD;
             Class III])&#xD;
&#xD;
          -  For participants with perennial allergic rhinitis: a positive skin test (wheal &gt;=3 mm&#xD;
             greater than saline control) to one of the relevant perennial allergens or a positive&#xD;
             RAST (defined as a score &gt;= Class III)&#xD;
&#xD;
          -  Nonsmoker and has been a nonsmoker for at least 1 year prior to study Visit 1 with a&#xD;
             smoking history of no more than 10 pack-years (1 pack [20 cigarettes] per day for 10&#xD;
             years)&#xD;
&#xD;
          -  Must be in good and stable physical health and mental health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalization or hospitalization within 4 weeks of the first scheduled study visit&#xD;
&#xD;
          -  Pregnancy or within &lt;= 8 weeks postpartum or is breast feeding&#xD;
&#xD;
          -  Any major surgical procedure within 4 weeks of the first scheduled study vist&#xD;
&#xD;
          -  Current or recent past abuser of alcohol or illicit drugs&#xD;
&#xD;
          -  Prior participation in a clinical trial of montelukast or loratadine within the 4&#xD;
             weeks prior to the first scheduled study visit&#xD;
&#xD;
          -  Requires treatment other than inhaled short-acting β-agonist for asthma&#xD;
&#xD;
             (e.g., inhaled or oral corticosteroid, theophylline, nedocromil, cromolyn, oral or&#xD;
             long-acting inhaled β-agonist, leukotriene receptor antagonist, leukotriene synthesis&#xD;
             inhibitor) and/or uses more than 8 puffs per day of inhaled short-acting β-agonist&#xD;
&#xD;
          -  Presence of an upper respiratory tract infection (URI), sinusitis, infectious rhinitis&#xD;
             (with symptoms such as sore throat, fever, thick purulent rhinorrhea), ocular&#xD;
             infection, or history of any of these within 4 weeks prior to the first scheduled&#xD;
             study visit or any time between study Visits 1 and 2&#xD;
&#xD;
          -  Other than asthma, any active, acute, or chronic pulmonary disorder which is&#xD;
             documented by history or physical examination&#xD;
&#xD;
          -  Rhinitis medicamentosa, or non-allergic rhinitis&#xD;
&#xD;
          -  Recent history (within 3 months prior to the first scheduled study visit) of a&#xD;
             clinically significant psychiatric disorder&#xD;
&#xD;
          -  History of an anaphylactic reaction to or is otherwise hypersensitive to&#xD;
&#xD;
        montelukast, loratadine, or one of their components&#xD;
&#xD;
          -  History or current evidence of any general medical condition, concomitant therapy, lab&#xD;
             abnormality or other circumstance that might confound the results of the study or&#xD;
             interfere with the patient's participation for the full duration of the study&#xD;
&#xD;
          -  History of illness that would require treatment with an excluded medication, could be&#xD;
             immediately life threatening (ventricular arrhythmia, diabetes mellitus that is not&#xD;
             well controlled), would pose restriction on participation or successful completion of&#xD;
             the study, or would pose additional risk to the patient by administering the study&#xD;
             drug&#xD;
&#xD;
          -  History of malignancy ≤5 years prior to signing informed consent, except for&#xD;
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Mexico</country>
  </removed_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>November 6, 2014</results_first_submitted>
  <results_first_submitted_qc>November 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 14, 2014</results_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loratadine</mesh_term>
    <mesh_term>Montelukast</mesh_term>
  </intervention_browse>
  <study_docs>
    <study_doc>
      <doc_type>CSR Synopsis</doc_type>
      <doc_url>http://www.merck.com/clinical-trials/study.html?id=0476A-484&amp;kw=0476A-484&amp;tab=access</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Montelukast 10 mg/Loratadine 10 mg</title>
          <description>Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants receive matching placebo tablets once daily for 2 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" 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="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Montelukast 10 mg/Loratadine 10 mg</title>
          <description>Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants receive matching placebo tablets once daily for 2 weeks</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="47"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="69"/>
          </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="29.7" spread="12.5"/>
                    <measurement group_id="B2" value="31.9" spread="9.3"/>
                    <measurement group_id="B3" value="30.4" spread="11.6"/>
                  </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="30"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing at Least One Adverse Event (AE)</title>
        <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
        <time_frame>Up to 4 weeks</time_frame>
        <population>The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Montelukast 10 mg/Loratadine 10 mg</title>
            <description>Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants receive matching placebo tablets once daily for 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing at Least One Adverse Event (AE)</title>
          <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
          <population>The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Discontinuing Study Treatment Due to AEs</title>
        <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
        <time_frame>Up to 2 weeks</time_frame>
        <population>The APaT population consisted of all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Montelukast 10 mg/Loratadine 10 mg</title>
            <description>Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants receive matching placebo tablets once daily for 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Treatment Due to AEs</title>
          <description>An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.</description>
          <population>The APaT population consisted of all randomized participants who received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 4 weeks</time_frame>
      <desc>The APaT population consisted of all randomized participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Montelukast 10 mg/Loratadine 10 mg</title>
          <description>Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants receive matching placebo tablets once daily for 2 weeks</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="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.1</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="3" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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 study 60 days prior to submission for publication/presentation.</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/NCT01673620
org study id: 0476A-484
nct id: NCT01673620
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and tolerability of montelukast 10
      mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Experiencing at Least One Adverse Event (AE)
time frame: Up to 4 weeks
description: An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
measure: Number of Participants Discontinuing Study Treatment Due to AEs
time frame: Up to 2 weeks
description: An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
arm group label: Montelukast 10 mg/loratadine 10 mg
arm group type: Experimental
description: Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo tablet administered orally once daily for 2 weeks
intervention type: Drug
intervention name: Montelukast 10 mg/loratadine 10 mg
description: Montelukast 10 mg/loratadine 10 mg tablet administered once daily
arm group label: Montelukast 10 mg/loratadine 10 mg
other name: MK-0476A
intervention type: Drug
intervention name: Placebo
description: Matching placebo tablet administered once daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: No
country: Mexico
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Loratadine
mesh term: Montelukast
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 