UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041693
Receipt number 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 2022/09/07 21:30:47

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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 or person

Institute

Yokohama City Minato Red Cross Hospital

Medical Center for Allergic and Immune Diseases

Institute

Department

Personal name



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

979

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Researcher's personal reasons

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

2022 Year 09 Month 07 Day



Link to view the page

Value
https://center6.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