UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012391
Receipt number R000014490
Scientific Title rush oral immunotherapy of milk allergy
Date of disclosure of the study information 2013/11/24
Last modified on 2020/06/11 11:38:05

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Basic information

Public title

rush oral immunotherapy of milk allergy

Acronym

rush ofmilk

Scientific Title

rush oral immunotherapy of milk allergy

Scientific Title:Acronym

rush ofmilk

Region

Japan


Condition

Condition

milk allergy

Classification by specialty

Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

oral tolerannce induction of milk allergy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

threthhold level of milk after 6 months

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

20ml of milk intake

Interventions/Control_2

100ml of milk intake

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

5 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

milk allergy

Key exclusion criteria

no milk allergy

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yuri
Middle name
Last name takaoka

Organization

oosaka prefectural respuratory and allergy center

Division name

pediatrics

Zip code

6390245

Address

3-7-1 habikino habikino-city

TEL

072-957-2121

Email

takaokayu@ra.opho.jp


Public contact

Name of contact person

1st name Yuri
Middle name
Last name takaoka

Organization

oosaka prefectural respuratory and allergy center

Division name

pediatrics

Zip code

5838588

Address

3-7-1 habikino habikino-city

TEL

072-957-2121

Homepage URL


Email

takaokayu@ra.opho.jp


Sponsor or person

Institute

oosaka prefectural respuratory and allergy center

Institute

Department

Personal name



Funding Source

Organization

no

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

osaka Habikino medical center

Address

3-7-1,Habikino,Habikino City

Tel

0729572121

Email

zvb11075@nifty.com


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

2013 Year 11 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

33

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

Completed

Date of protocol fixation

2013 Year 01 Month 30 Day

Date of IRB

2013 Year 01 Month 30 Day

Anticipated trial start date

2013 Year 02 Month 18 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 23 Day

Last modified on

2020 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014490


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name