UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008688 |
|---|---|
| Receipt number | R000010213 |
| Scientific Title | Usefulness and safety of Omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2012/08/14 19:40:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Usefulness and safety of Omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy
Acronym
Usefulness and safety of Omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy
Scientific Title
Usefulness and safety of Omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy
Scientific Title:Acronym
Usefulness and safety of Omalizumab (anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness and safety of Omalizumab(anti-IgE monoclonal antibody) on oral immunotherapy for patients with severe food allergy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Analysis of liquidity factors
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 | Food |
Interventions/Control_1
Omalizumab
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.More than 5 years old
2.Food allergy with hen's egg,cow milk, wheat and peanuts
3.Written Informed Consent
Key exclusion criteria
Decision of ineligibility by a physician.
Target sample size
40
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
10-15, Fumizono-cho, Moriguchi-City, Osaka
TEL
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
TEL
Homepage URL
taniuchi@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
関西医科大学附属滝井病院（大阪府）、関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | 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
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | 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
| 2012 | Year | 08 | Month | 14 | Day |
Last modified on
| 2012 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010213
