UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024397 |
|---|---|
| Receipt number | 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 16:28:09 |
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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
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
taniuchi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028078
