<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/NCT03293225</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-17-173</org_study_id>
    <nct_id>NCT03293225</nct_id>
  </id_info>
  <brief_title>Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist</brief_title>
  <acronym>OPEhRA</acronym>
  <official_title>A Randomized Open Labeled Trial to Compare the Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist in Patients With Chronic Urticaria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on&#xD;
      treatment with H2-receptor antagonist in patients with chronic urticaria&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  For four weeks&#xD;
&#xD;
        -  After the researcher confirms the selection / exclusion criteria on the baseline, the&#xD;
           UAS, K-UCT, and CU-QoL are created and randomized from the subject.&#xD;
&#xD;
        -  Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">May 24, 2019</completion_date>
  <primary_completion_date type="Actual">May 24, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Weeks</target_duration>
  <primary_outcome>
    <measure>Number of evaluation after 4 weeks treatment by a investigator</measure>
    <time_frame>4 weeks</time_frame>
    <description>0-no effective, 1-ineffective, 2-effective, 3-no symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peripheral blood eosinophil count</measure>
    <time_frame>4 weeks</time_frame>
    <description>in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of evaluation as assessed by questionnaire</measure>
    <time_frame>4 weeks</time_frame>
    <description>Sleepiness, dryness, dysuria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of urticaria control by K-UCT</measure>
    <time_frame>4 weeks</time_frame>
    <description>Before and after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of urticaria symptom by UAS</measure>
    <time_frame>4 weeks</time_frame>
    <description>Urticaria activity score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of chronic urticaria by CU-QoL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quality of life questionnaire for patients with chronic urticaria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patient-controlled urticaria by VAS</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluation of Patient-controlled urticaria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using emergency medication</measure>
    <time_frame>4 weeks</time_frame>
    <description>Emergency drug frequency in patients with chronic urticaria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Serum total IgE</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison each group in treatment activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of physiological parameter</measure>
    <time_frame>4 weeks</time_frame>
    <description>weight gain in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of creatinine, AST/ALT</measure>
    <time_frame>4 weeks</time_frame>
    <description>Creatinine in mg/dl, AST/ALT in UL</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Chronic Urticaria</condition>
  <arm_group>
    <arm_group_label>add H2RA</arm_group_label>
    <description>Add antihistamines to standard drug therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>change ns-H1RA</arm_group_label>
    <description>Change to ns-H1RA in standard medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ns-H1RA(3-4 tabs)</arm_group_label>
    <description>Standard treatment with ns-H1RA 4X dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ns-H1RA(3-4kinds)</arm_group_label>
    <description>Use of NS 4 kinds for standard treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic urticaria in Ajou University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents and adults over 12 years&#xD;
&#xD;
          -  Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema&#xD;
             over 6 weeks&#xD;
&#xD;
          -  Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are&#xD;
             not controlled&#xD;
&#xD;
          -  Those who do not have other chronic skin diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Youngmin Ye, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Ajou University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou University Medical Hospital</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ye Youngmin</investigator_full_name>
    <investigator_title>professor, Department alleric internal medicine</investigator_title>
  </responsible_party>
  <keyword>cu</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03293225
org study id: AJIRB-MED-OBS-17-173
nct id: NCT03293225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on
      treatment with H2-receptor antagonist in patients with chronic urticaria
-  For four weeks

        -  After the researcher confirms the selection / exclusion criteria on the baseline, the
           UAS, K-UCT, and CU-QoL are created and randomized from the subject.

        -  Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety
observational model: Case-Control
time perspective: Prospective
measure: Number of evaluation after 4 weeks treatment by a investigator
time frame: 4 weeks
description: 0-no effective, 1-ineffective, 2-effective, 3-no symptoms
measure: Peripheral blood eosinophil count
time frame: 4 weeks
description: in percentage
measure: Number of evaluation as assessed by questionnaire
time frame: 4 weeks
description: Sleepiness, dryness, dysuria
measure: Number of urticaria control by K-UCT
time frame: 4 weeks
description: Before and after treatment
measure: Number of urticaria symptom by UAS
time frame: 4 weeks
description: Urticaria activity score
measure: Quality of life of chronic urticaria by CU-QoL
time frame: 4 weeks
description: Quality of life questionnaire for patients with chronic urticaria
measure: Number of Patient-controlled urticaria by VAS
time frame: 4 weeks
description: evaluation of Patient-controlled urticaria
measure: Number of patients using emergency medication
time frame: 4 weeks
description: Emergency drug frequency in patients with chronic urticaria
measure: Comparison of Serum total IgE
time frame: 4 weeks
description: Comparison each group in treatment activity
measure: Number of physiological parameter
time frame: 4 weeks
description: weight gain in kilograms
measure: Number of creatinine, AST/ALT
time frame: 4 weeks
description: Creatinine in mg/dl, AST/ALT in UL
arm group label: add H2RA
description: Add antihistamines to standard drug therapy
arm group label: change ns-H1RA
description: Change to ns-H1RA in standard medication
arm group label: ns-H1RA(3-4 tabs)
description: Standard treatment with ns-H1RA 4X dose
arm group label: ns-H1RA(3-4kinds)
description: Use of NS 4 kinds for standard treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Youngmin Ye, Dr
role: Study Director
affiliation: Ajou University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Ye Youngmin
investigator title: professor, Department alleric internal medicine
mesh term: Urticaria
mesh term: Chronic Urticaria
sharing ipd: No