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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024397
Receipt No. R000028078
Scientific Title Efficacy and safety of oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Date of disclosure of the study information 2016/12/01
Last modified on 2016/10/13

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Basic information
Public title Efficacy and safety of oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Acronym Oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Scientific Title Efficacy and safety of oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Scientific Title:Acronym Oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the efficacy and safety for long period after the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentages of sustained unresponsiveness at the months 18 after the start of the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
Key secondary outcomes The frequencies of allergic reactions from the start to the months 18 after the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 To examine the efficacy and safety for months 18 at the start of the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
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
6 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria 1.Children who gain desensitization of cow's milk after the randomized study of oral immunotherapy for severe cow's milk allergy and who continue daily cow's milk ingestion.
2. Children who obtain the informed consent of the study
Key exclusion criteria 1. Children who have acute disease and chronic disease except allergic disease.

2.Children or guardian who deny the study
3. Children who were judged as inappropriate by the study director
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Taniuchi
Organization Kansai Medical University
Division name Department of Pediatrics
Zip code
Address 2-5-1, Shinmachi Hirakata city, Osaka, Japan
TEL 072-804-0101
Email taniuchi@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichiro Taniuchi
Organization Kansai Medical University
Division name Department of Pediatrics
Zip code
Address 2-5-1, Shinmachi Hirakata city, Osaka, Japan
TEL 072-804-0101
Homepage URL
Email taniuchi@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 関西医科大学

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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 07 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2016 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028078

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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