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

Chronic Urticaria Clinical Trial

— OPEhRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293225
• Other study ID #: AJIRB-MED-OBS-17-173
• Status: Completed
• Start date: August 24, 2017
• Est. completion date: May 24, 2019

Study information

• Verified date: July 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Hospital	Suwon-si

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of evaluation after 4 weeks treatment by a investigator	0-no effective, 1-ineffective, 2-effective, 3-no symptoms	4 weeks
Secondary	Peripheral blood eosinophil count	in percentage	4 weeks
Secondary	Number of evaluation as assessed by questionnaire	Sleepiness, dryness, dysuria	4 weeks
Secondary	Number of urticaria control by K-UCT	Before and after treatment	4 weeks
Secondary	Number of urticaria symptom by UAS	Urticaria activity score	4 weeks
Secondary	Quality of life of chronic urticaria by CU-QoL	Quality of life questionnaire for patients with chronic urticaria	4 weeks
Secondary	Number of Patient-controlled urticaria by VAS	evaluation of Patient-controlled urticaria	4 weeks
Secondary	Number of patients using emergency medication	Emergency drug frequency in patients with chronic urticaria	4 weeks
Secondary	Comparison of Serum total IgE	Comparison each group in treatment activity	4 weeks
Secondary	Number of physiological parameter	weight gain in kilograms	4 weeks
Secondary	Number of creatinine, AST/ALT	Creatinine in mg/dl, AST/ALT in UL	4 weeks