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CompletedNCT03293225OPEhRAUpdated Jul 8, 2019

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

An observational study in Chronic Urticaria, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Ajou University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
110
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Chronic Urticaria with a site in Korea, Republic of — 4 open to participants now, 7 under way, 5 of them phase 3. Chronic Urticaria · Korea, Republic of.

Started
2017
the only one that year
Observational
Only one
of the 16
Registered
1st of 16
by date
Lead sponsor
1 of 16
Ajou University School of Medicine

Among the 16 studies in Chronic Urticaria with a site in Korea, Republic of, this one is the only one that started in 2017, is the only observational one, and was the 1st registered.

Chronic Urticaria

194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.

Browse Chronic Urticaria studies →

Open to participants now

4 of the 16 studies in Chronic Urticaria with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 24 Chronic Urticaria studies recruiting now, 11 (46%) set no upper age limit and 9 (38%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 12 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Chronic Urticaria with a site in Korea, Republic of, or all of them as a file.
02

Study 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

Read the 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
03

Conditions studied

  • Chronic Urticaria

Browse trials for

Keywords

  • cu
04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic urticaria in Ajou University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
110 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 4 weeks

Secondary outcomes

  1. Peripheral blood eosinophil count

    in percentage

    Time frame: 4 weeks

  2. Number of evaluation as assessed by questionnaire

    Sleepiness, dryness, dysuria

    Time frame: 4 weeks

  3. Number of urticaria control by K-UCT

    Before and after treatment

    Time frame: 4 weeks

  4. Number of urticaria symptom by UAS

    Urticaria activity score

    Time frame: 4 weeks

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

    Quality of life questionnaire for patients with chronic urticaria

    Time frame: 4 weeks

  6. Number of Patient-controlled urticaria by VAS

    evaluation of Patient-controlled urticaria

    Time frame: 4 weeks

  7. Number of patients using emergency medication

    Emergency drug frequency in patients with chronic urticaria

    Time frame: 4 weeks

  8. Comparison of Serum total IgE

    Comparison each group in treatment activity

    Time frame: 4 weeks

  9. Number of physiological parameter

    weight gain in kilograms

    Time frame: 4 weeks

  10. Number of creatinine, AST/ALT

    Creatinine in mg/dl, AST/ALT in UL

    Time frame: 4 weeks

07

Study locations

1 site
  • Ajou University Medical Hospital
    Suwon-si, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in May 2019, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 26, 2017
StartActual
Aug 24, 2017
Primary completionActual
May 24, 2019
CompletionActual
May 24, 2019
Last update
Jul 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03293225
Responsible party
Ye Youngmin (professor, Department alleric internal medicine, Ajou University School of Medicine) — Principal investigator
First posted
Sep 26, 2017
Start date
Aug 24, 2017
Primary completion
May 24, 2019
Completion
May 24, 2019
Last update
Jul 8, 2019

Study contacts

Youngmin Ye, Dr
study director · Ajou University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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