<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/NCT02238236</url>
  </required_header>
  <id_info>
    <org_study_id>262.293</org_study_id>
    <nct_id>NCT02238236</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus</brief_title>
  <official_title>Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Drug Use-Results Survey of Alesion® Dry Syrup-</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in&#xD;
      daily clinical practice in Japanese paediatric patients with allergic rhinitis,&#xD;
      eczema/dermatitis, urticaria and pruritus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <primary_completion_date type="Actual">April 2008</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse drug reactions</measure>
    <time_frame>up to 3 years</time_frame>
    <description>classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse drug reactions classified by patient's background/treatment factors</measure>
    <time_frame>up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall assessment of efficacy by investigator on a 3-point scale</measure>
    <time_frame>At 12 weeks and 52 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3793</enrollment>
  <condition>Rhinitis, Allergic, Perennial</condition>
  <arm_group>
    <arm_group_label>Patients with allergic rhinitis, eczema/dermatitis, urticaria</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alesion®</intervention_name>
    <description>Dry Syrup</description>
    <arm_group_label>Patients with allergic rhinitis, eczema/dermatitis, urticaria</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Paediatric patients without experience in Treatment with epinastine are selected by&#xD;
        physicians at medical institutions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the patients who:&#xD;
&#xD;
               -  haven't treatment experience of epinastine product;&#xD;
&#xD;
               -  have at least one out of following diseases. allergic rhinitis, eczema,&#xD;
                  dermatitis, pruritus, urticaria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alesion® Dry Syrup is contraindicated for the patients with history of&#xD;
             hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However,&#xD;
             it was unknown whether a patient was hypersensitive to the ingredients of the product&#xD;
             in almost cases. And this survey was drug utilization study to observe actual use in&#xD;
             any patients. Therefore exclusion criteria are not set in the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238236
org study id: 262.293
nct id: NCT02238236
lead sponsor: 
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in
      daily clinical practice in Japanese paediatric patients with allergic rhinitis,
      eczema/dermatitis, urticaria and pruritus
observational model: Cohort
time perspective: Prospective
measure: Incidence of adverse drug reactions
time frame: up to 3 years
description: classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
measure: Incidence of adverse drug reactions classified by patient's background/treatment factors
time frame: up to 3 years
measure: Overall assessment of efficacy by investigator on a 3-point scale
time frame: At 12 weeks and 52 weeks
arm group label: Patients with allergic rhinitis, eczema/dermatitis, urticaria
intervention type: Drug
intervention name: Alesion®
description: Dry Syrup
arm group label: Patients with allergic rhinitis, eczema/dermatitis, urticaria
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial