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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015545
Receipt No. R000018064
Scientific Title Efficacy and safety of omalizumab (anti-IgE monoclinal antibody) on oral immunotherapy for patients with cow's milk allergy (randomized control study)
Date of disclosure of the study information 2014/11/01
Last modified on 2018/04/16

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Basic information
Public title Efficacy and safety of omalizumab (anti-IgE monoclinal antibody) on oral immunotherapy for patients with cow's milk allergy (randomized control study)
Acronym Omalizumab on oral immunotherapy for patients with cow's milk allergy
Scientific Title Efficacy and safety of omalizumab (anti-IgE monoclinal antibody) on oral immunotherapy for patients with cow's milk allergy (randomized control study)
Scientific Title:Acronym Omalizumab on oral immunotherapy for patients with cow's milk allergy
Region
Japan

Condition
Condition food allergy
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy patients with cow's milk allergy using randomized control study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the symptom provocation threshold change at the time of entry and 8 months after the start of administration of Omalizumab.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 omalizmab
Interventions/Control_2 cow's milk
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) The patients that have anaphylaxy with less 10ml of cow's milk product for 2 years or have symptoms of more than grade 2 according to Sampson's score
2) The patients that show more than 17.5 UA/mL of specific cow's milk IgE level.
3) Positive double blind challenge by cow's milk
4) The patients that written informed consent is obtained
5) The patients that show more than 3 mm of wheel (diameter) by skin prick test.
Key exclusion criteria 1) severe bronchial asthma
2) severe atopic dermatitis
3) acute severe illenes
4) Decision of ineligibility by a physician.
Target sample size 50

Research contact person
Last 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 2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL 072-804-0101
Email taniuchi@hirakata.kmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shoichiro Taniuchi
Organization Kansai Medical University
Division name Department of Pediatrics
Zip code
Address 2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL 072-804-0101
Homepage URL
Email taniuchi@hirakata.kmu.ac.jp

Sponsor
Institute The Mami Mizutani foundation
Kansai Medical University

Institute
Department

Funding Source
Organization The Mami Mizutani foundation
Kansai Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-017-16730-6
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
2014 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2016 Year 10 Month 31 Day
Date trial data considered complete
2016 Year 10 Month 31 Day
Date analysis concluded
2017 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 28 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/04/16 OMB OIT CM .pdf


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