UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Japanese anaphylaxis registry
Title of the study (Brief title)	Multicenter Japanese anaphylaxis registry
Region	Japan

Condition
Condition	Anaphylaxis
Classification by specialty	Medicine in general Clinical immunology Pediatrics Ophthalmology Dermatology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the causes and clinical course of anaphylaxis in Japan.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The purpose of this study is to clarify causes of anaphylaxis in Japan.
Key secondary outcomes	To evaluate as follows; 1)Severity of anaphylaxis 2)Outcome of anaphylaxis 3)Difference of cause by region and season 4) Rate of adrenaline self-injection use 5)Prescription of adrenaline self-injection when going home, and education contents

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The anaphylaxis subjects who visited at the recognized training facilities of Japanese Society of Allergology. Definition of anaphylaxis is based on World Allergy Organization guidelines for the assessment and management of anaphylaxis.
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	Motohiro Ebisawa
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL	042-742-8311
Email	foodallergy@sagamihara-hosp.gr.jp

Public contact
Name of contact person	Sakura Sato
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL	042-742-8311
Homepage URL
Email	s-satou@sagamihara-hosp.gr.jp

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	Pfizer
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	The recognized training facilities of Japanese Society of Allergology
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立病院機構　相模原病院　小児科（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 02 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 25 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To analyze the relationship between causes, triggers, patients characteristics and clinical course of anaphylaxis

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2017 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019358