Efficacy of Antihistamine Dosing-up and add-on Treatment... | NCT03293225

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

NCT03293225

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Chronic Urticaria

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2017Actual

Primary Completion Date

May 24, 2019Actual

Completion Date

May 24, 2019Actual

First Submitted Date

Sep 11, 2017

First Submission Date that Met QC Criteria

Sep 24, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2019

Last Update Posted Date

Jul 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ye Youngmin, professor, Department alleric internal medicine, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Peripheral blood eosinophil count	in percentage	4 weeks
Number of evaluation as assessed by questionnaire	Sleepiness, dryness, dysuria

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Chronic urticaria in Ajou University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youngmin Ye, Dr	Ajou University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Medical Hospital		Suwon			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000080223	Chronic Urticaria

Ancestor Terms

ID	Term
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided