UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014272 |
|---|---|
| Receipt number | R000016606 |
| Scientific Title | Evaluation of anti-IgE antibody therapy in the patients with wheat allergy |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2016/11/22 11:53:42 |
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Basic information
Public title
Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Acronym
Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Scientific Title
Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Scientific Title:Acronym
Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Region
| Japan |
Condition
Condition
Wheat allergy
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic efficacy of anti-IgE antibody (Omalizumab) in the patients with wheat allergy, and to establish its treatment methodology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the sensitization status before and after the therapy using basophil activation test, specific IgE test, and enzyme-linked immunosorbent assay.
Key secondary outcomes
Food challenge test before and after the treatment if available.
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
Subcutaneous injection of 150 mg of Omalizumab (Novartis Pharma, Japan) once every four weeks, 3 times in all.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had an allergic reaction to wheat within three months, or patients who avoid wheat ingestion because of the high titer of wheat-specific IgE.
Key exclusion criteria
Patients who had been administrated of Omalizumab in history, and patients who receive immunosuppressive drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Chinuki |
Organization
Shimane University Hospital
Division name
Dermatology
Zip code
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
ychinuki@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Chinuki |
Organization
Shimane University Hospital
Division name
Dermatology
Zip code
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
Homepage URL
ychinuki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Research Center for Prevention of Lifestyle-Related Disease
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujita Health University
Tokyo Medical and Dental University
Osaka University
Hiroshima University
Hyogo Prefectural Kakogawa Medical Center
National Hospital Organization, Sagamihara National Hospital
National Hospital Organization, Fukuoka National Hospital
Name of secondary funder(s)
Yuuka Co., Ltd.
KATAYAMA CHEMICAL, INC
PHOENIX Co., Ltd.
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
島根大学（島根県）
藤田保健衛生大学（愛知県）
東京医科歯科大学（東京都）
大阪大学（大阪府）
広島大学（広島県）
兵庫県立加古川医療センター（兵庫県）
国立病院機構相模原病院（神奈川県）
国立病院機構福岡病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016606
