UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015545 |
|---|---|
| Receipt number | 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 10:56:55 |
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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
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
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
2-3-1, shinmachi, Hirakata city, Osaka, Japan
TEL
072-804-0101
Homepage URL
taniuchi@hirakata.kmu.ac.jp
Sponsor or person
Institute
The Mami Mizutani foundation
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
