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Completed

NCT Number: NCT03293225

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

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

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University Medical Hospital

Suwon, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 4 weeks

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

Secondary outcomes

  1. Peripheral blood eosinophil count

    Time frame: 4 weeks

    in percentage

  2. Number of evaluation as assessed by questionnaire

    Time frame: 4 weeks

    Sleepiness, dryness, dysuria

  3. Number of urticaria control by K-UCT

    Time frame: 4 weeks

    Before and after treatment

  4. Number of urticaria symptom by UAS

    Time frame: 4 weeks

    Urticaria activity score

  5. Quality of life of chronic urticaria by CU-QoL

    Time frame: 4 weeks

    Quality of life questionnaire for patients with chronic urticaria

  6. Number of Patient-controlled urticaria by VAS

    Time frame: 4 weeks

    evaluation of Patient-controlled urticaria

  7. Number of patients using emergency medication

    Time frame: 4 weeks

    Emergency drug frequency in patients with chronic urticaria

  8. Comparison of Serum total IgE

    Time frame: 4 weeks

    Comparison each group in treatment activity

  9. Number of physiological parameter

    Time frame: 4 weeks

    weight gain in kilograms

  10. Number of creatinine, AST/ALT

    Time frame: 4 weeks

    Creatinine in mg/dl, AST/ALT in UL

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study 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

Acronym: OPEhRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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