UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016682 |
|---|---|
| Receipt number | R000019358 |
| Scientific Title | Multicenter Japanese anaphylaxis registry |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2017/03/03 10:07:53 |
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Basic information
Public title
Multicenter Japanese anaphylaxis registry
Acronym
Multicenter Japanese anaphylaxis registry
Scientific Title
Multicenter Japanese anaphylaxis registry
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Motohiro Ebisawa |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
foodallergy@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakura Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
Homepage URL
s-satou@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019358
