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

Completed

• Conditions: Chronic Urticaria

• Registration Number: NCT03293225
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-08-24
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-26
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of urticaria symptom by UAS	4 weeks	Urticaria activity score
Number of creatinine, AST/ALT	4 weeks	Creatinine in mg/dl, AST/ALT in UL
Peripheral blood eosinophil count	4 weeks	in percentage
Number of urticaria control by K-UCT	4 weeks	Before and after treatment
Number of evaluation as assessed by questionnaire	4 weeks	Sleepiness, dryness, dysuria
Quality of life of chronic urticaria by CU-QoL	4 weeks	Quality of life questionnaire for patients with chronic urticaria
Number of Patient-controlled urticaria by VAS	4 weeks	evaluation of Patient-controlled urticaria
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

Trial Locations

Locations (1)

Ajou University Medical Hospital; 🇰🇷 Suwon-si, Korea, Republic of