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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018794
Receipt No. R000021080
Scientific Title A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Date of disclosure of the study information 2015/08/25
Last modified on 2019/03/07

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Basic information
Public title A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Acronym A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
Scientific Title A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Scientific Title:Acronym A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
Region
Japan

Condition
Condition Cow's milk allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To perform oral immunotherapy (OIT) for cow's milk allergy diagnosed by oral challenge test in combination with anti-IgE therapy and to compare frequency and severity of adverse events until reaching the target amount with conventional OIT.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral immunotherapy in combination with ant-IgE therapy.Patients are administered with omalizumab at four-weekly intervals for 20 weeks from enrollment. The appropriate dose of omalizumab is determined according to administration criteria of asthma.
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
20 years-old >=
Gender Male and Female
Key inclusion criteria 1)Severe cow's milk allergic patients between 6-20 years diagnosed by oral challenge test within 3 months. Threshold must be less than 3ml.
2)Patients, whose dose of Xolair (omalizumab) according to administration criteria of asthma is less than 150mg/month.
Key exclusion criteria 1)Patients with past history of tracheal tubing or ICU admission due to anaphylaxis to foods.
2)Patients with severe systemic disease (Heart diseases, Inflammatory diseases, uncontrolled baronchial asthma).
3)Patients using beta blocker.
4)Patients with past history of hypersensitivity to omalizumab.
5)Patients who do not agree to participate in this study.
6)Patients whom physician regards inadequate.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuya Tsuge
Organization Fujita Health university
Division name Faculty of medicine, Department of pediatrics.
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL +81-562-93-9251
Email itsuge@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuya Tsuge
Organization Fujita Health university
Division name Faculty of medicine, Department of pediatrics.
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL +81-562-93-9251
Homepage URL
Email itsuge@fujita-hu.ac.jp

Sponsor
Institute Fujita Health university
Faculty of medicine, Department of pediatrics.
Institute
Department

Funding Source
Organization Fujita Health University Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 25 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
2015 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 25 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021080

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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