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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024564
Receipt No. R000028272
Scientific Title Efficacy and safety of epicutaneous immunotherapy for severe milk allergy
Date of disclosure of the study information 2016/11/01
Last modified on 2019/05/08

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Basic information
Public title Efficacy and safety of epicutaneous immunotherapy for severe milk allergy
Acronym Epicutaneous immunotherapy for milk allergy
Scientific Title Efficacy and safety of epicutaneous immunotherapy for severe milk allergy
Scientific Title:Acronym Epicutaneous immunotherapy for milk allergy
Region
Japan

Condition
Condition Food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Oral immunotherapy has been shown to have some efficacy in inducing desensitization for patients with severe unremitting food allergy. However, limitation has also been shown in terms of its side effects and difficulty in inducing tolerance. Safer and more effective therapy is needed. In this study, we aim to investigate efficacy and safety of an epicutaneous immunotherapy by using a novel transcutaneous antigen delivery device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Proportion of the subjects who tolerate more than 3 ml of milk (total dose) at oral milk challenge after the treatment for 24 weeks
Key secondary outcomes 1.Safety: local reaction, systemic immediate-type allergic reaction and other
2.Prick test
3.Specific IgE and IgG4

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Cutaneous application of hydrogel patch containing cow's milk concentrate for 12 hours a day for 24 weeks
Interventions/Control_2 Cutaneous application of simple hydrogel patch for 12 hours a day for 24 weeks
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
2 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) Milk allergy diagnosed by oral food challenge (OFC) without tendency of natural outgrow
2) Mlik dose threshold of OFC =<3ml(total dose)
Key exclusion criteria 1)patients whose intake levels of milk changed within 3 months of the trial
2)patients who had milk oral immunotherapy within 6 months
3) patients who are on other immunotherapy
4)patients who have heart, liver and kidney diseases
5)patients with ncontrolled asthma or atopic dermatitis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Fujisawa
Organization National Hospital Organization Mie National Hospital
Division name Allergy center
Zip code
Address 357 Osato-kubota, Tsu, Mie, Japan
TEL +81592322531
Email fujisawa@mie-m.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Kuwabara
Organization National Hospital Organization Mie National Hospital
Division name Allergy center
Zip code
Address 357 Osato-kubota, Tsu, Mie, Japan
TEL +81592322531
Homepage URL
Email yu_surrealist@hotmail.co.jp

Sponsor
Institute National Hospital Organization Mie National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立病院機構三重病院、国立病院機構相模原病院、福井大学病院、群馬大学病院、獨協医大病院、千葉大学病院、、国立病院機構下志津病院、、千葉県子ども病院、富山大学病院、あいち小児保健医療総合センター、大阪府立呼吸器アレルギー医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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 Completed
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
2016 Year 10 Month 12 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 25 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028272

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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