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OPEhRA: Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03293225
Collaborator
(none)
110
Enrollment
1
Location
21
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • 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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    110 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Aug 24, 2017
    Actual Primary Completion Date :
    May 24, 2019
    Actual Study Completion Date :
    May 24, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    add H2RA

    Add antihistamines to standard drug therapy
    change ns-H1RA

    Change to ns-H1RA in standard medication
    ns-H1RA(3-4 tabs)

    Standard treatment with ns-H1RA 4X dose
    ns-H1RA(3-4kinds)

    Use of NS 4 kinds for standard treatment

    Outcome Measures

    Primary Outcome Measures

    1. Number of evaluation after 4 weeks treatment by a investigator [4 weeks]

      0-no effective, 1-ineffective, 2-effective, 3-no symptoms

    Secondary Outcome Measures

    1. Peripheral blood eosinophil count [4 weeks]

      in percentage

    2. Number of evaluation as assessed by questionnaire [4 weeks]

      Sleepiness, dryness, dysuria

    3. Number of urticaria control by K-UCT [4 weeks]

      Before and after treatment

    4. Number of urticaria symptom by UAS [4 weeks]

      Urticaria activity score

    5. Quality of life of chronic urticaria by CU-QoL [4 weeks]

      Quality of life questionnaire for patients with chronic urticaria

    6. Number of Patient-controlled urticaria by VAS [4 weeks]

      evaluation of Patient-controlled urticaria

    7. Number of patients using emergency medication [4 weeks]

      Emergency drug frequency in patients with chronic urticaria

    8. Comparison of Serum total IgE [4 weeks]

      Comparison each group in treatment activity

    9. Number of physiological parameter [4 weeks]

      weight gain in kilograms

    10. Number of creatinine, AST/ALT [4 weeks]

      Creatinine in mg/dl, AST/ALT in UL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adolescents and adults over 12 years

    • Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks

    • Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled

    • Those who do not have other chronic skin diseases

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajou University Medical Hospital Suwon-si Korea, Republic of

    Sponsors and Collaborators

    • Ajou University School of Medicine

    Investigators

    • Study Director: Youngmin Ye, Dr, Ajou University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ye Youngmin, professor, Department alleric internal medicine, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03293225
    Other Study ID Numbers:
    • AJIRB-MED-OBS-17-173
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Jul 8, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ye Youngmin, professor, Department alleric internal medicine, Ajou University School of Medicine
    cu
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria

    Study Results

    No Results Posted as of Jul 8, 2019