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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041693
Receipt No. R000047592
Scientific Title Internet survey on adrenaline auto-injector for patients with a history of anaphylaxis
Date of disclosure of the study information 2020/09/05
Last modified on 2020/09/05

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Basic information
Public title Internet survey on Epipen auto-injector for patients with a history of anaphylaxis
Acronym Internet survey on Epipen auto-injector
Scientific Title Internet survey on adrenaline auto-injector for patients with a history of anaphylaxis
Scientific Title:Acronym Internet survey on adrenaline auto-injector
Region
Japan

Condition
Condition Anaphylaxis or Anaphylactic shock
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to clarify the background factors of doctors, patients, and parents who need to be enlightened about anaphylaxis, whether or not they have been seen at a medical institution since the onset of anaphylaxis, the status of regular consultations for recurrence of anaphylaxis, the prescription status of adrenaline auto-injector.
Basic objectives2 Others
Basic objectives -Others actual condition survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Background factors for those with a history of anaphylaxis who do not have adrenaline auto-injector
Key secondary outcomes 1)Background factors by region for those with a history of anaphylaxis and who do not have adrenaline auto-injector
2)Background factors by age for those with a history of anaphylaxis and who do not have adrenaline auto-injector
3)Background factors by anaphylaxis onset and history of anaphylaxis patients who do not have adrenaline auto-injector
4)(First visit) Prescription rate of adrenaline auto-injector by department
5)(Family physician) Prescription rate of adrenaline auto-injector by department
6)Re-prescription status of adrenaline auto-injector
7)Relationship between parents and children with and without history, parents with and without history of anaphylaxis, and thought/behavioral patterns for adrenaline auto-injector

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 1. Large-scale panels, the panel that corresponds to any one or more of 1)allergic rhinitis 2)atopic dermatitis 3)bronchial asthma
2. Respondents who have had anaphylaxis in the past or their children
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yoichi
Middle name
Last name Nakamura
Organization Yokohama City Minato Red Cross Hospital
Division name Medical Center for Allergic and Immune Diseases
Zip code 231-8682
Address 3-12-1 Shin-yamashita, Naka-ku, Yokohama-city, Kanagawa
TEL 045-628-6381
Email nakamura.alle@yokohama.jrc.or.jp

Public contact
Name of contact person
1st name Yoichi
Middle name
Last name Nakamura
Organization Yokohama City Minato Red Cross Hospital
Division name Medical Center for Allergic and Immune Diseases
Zip code 231-8682
Address 3-12-1 Shin-yamashita, Naka-ku, Yokohama-city, Kanagawa
TEL 045-628-6381
Homepage URL
Email nakamura.alle@yokohama.jrc.or.jp

Sponsor
Institute Yokohama City Minato Red Cross Hospital

Medical Center for Allergic and Immune Diseases
Institute
Department

Funding Source
Organization Mylan EPD G.K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City Minato Red Cross Hospital
Address 3-12-1 Shin-yamashita, Naka-ku, Yokohama-city, Kanagawa
Tel 045-628-6100
Email y-yamanashi.ji@yokohama.jrc.or.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 05 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 29 Day
Date of IRB
2020 Year 08 Month 21 Day
Anticipated trial start date
2020 Year 09 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 09 Month 05 Day
Last modified on
2020 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047592

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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