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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03293225

Acronym

OPEhRA

Enrollment

110

Registered

2017-09-26

Start date

2017-08-24

Completion date

2019-05-24

Last updated

2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Urticaria

Keywords

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

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of evaluation after 4 weeks treatment by a investigator	4 weeks	0-no effective, 1-ineffective, 2-effective, 3-no symptoms

Secondary

Measure	Time frame	Description
Number of evaluation as assessed by questionnaire	4 weeks	Sleepiness, dryness, dysuria
Number of urticaria control by K-UCT	4 weeks	Before and after treatment
Number of urticaria symptom by UAS	4 weeks	Urticaria activity score
Quality of life of chronic urticaria by CU-QoL	4 weeks	Quality of life questionnaire for patients with chronic urticaria
Peripheral blood eosinophil count	4 weeks	in percentage
Number of patients using emergency medication	4 weeks	Emergency drug frequency in patients with chronic urticaria
Comparison of Serum total IgE	4 weeks	Comparison each group in treatment activity
Number of physiological parameter	4 weeks	weight gain in kilograms
Number of creatinine, AST/ALT	4 weeks	Creatinine in mg/dl, AST/ALT in UL
Number of Patient-controlled urticaria by VAS	4 weeks	evaluation of Patient-controlled urticaria

Countries

South Korea

Outcome results