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Trial record 3 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Histamine Antagonists"

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

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ClinicalTrials.gov Identifier: NCT03293225
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ye Youngmin, Ajou University School of Medicine

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
Chronic Urticaria

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 Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
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 : August 24, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic urticaria in Ajou University Hospital
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293225


Contacts
Contact: Hyunjung Kang, Nr 82-10-7321-7362 dusehthsu@gmail.com

Locations
Korea, Republic of
Ajou University Medical Hospital Recruiting
Suwon-si, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Study Director: Youngmin Ye, Dr Ajou University

Responsible Party: Ye Youngmin, professor, Department alleric internal medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03293225     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-17-173
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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, Ajou University School of Medicine:
cu

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine H2 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs