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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018179
Receipt No. R000021042
Scientific Title Analysis of prognosis of patients who were treated with oral immunotherapy.
Date of disclosure of the study information 2015/08/16
Last modified on 2015/07/03

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Basic information
Public title Analysis of prognosis of patients
who were treated with oral immunotherapy.
Acronym Prognosis after completing oral immunotherapy.
Scientific Title Analysis of prognosis of patients
who were treated with oral immunotherapy.
Scientific Title:Acronym Prognosis after completing oral immunotherapy.
Region
Japan

Condition
Condition Food Allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the prognosis of patients who were treated with oral immunotherapy.
Basic objectives2 Others
Basic objectives -Others Rate of patients who experienced allergic reactions after completing oral immunotherapy.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Rate of patients who experienced allergic reactions after completing oral immunotherapy.
Key secondary outcomes 1.Rate of patients who used
adrenaline self-injector.
2.Consumption frequency of tolerated foods.
3.Consumption of tolerated foods with or without reluctance.
4.Consumption of tolerated foods
and allergic reactions experienced at school.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 received oral
immunotherapy for an allergy to egg,
cow's milk, wheat or peanut, and had
been judged to be tolerant more than one year.
Key exclusion criteria Patients who did not agree to participate in the study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamiharashi, Kanagawa, Japan, 252-0392.
TEL 042-742-8311
Email foodallergy@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakura Sato
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minami-ku, Sagamiharashi, Kanagawa, Japan, 252-0392.
TEL 042-742-8311
Homepage URL
Email s-sato@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立病院機構相模原病院 (神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 08 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 Preinitiation
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Rate of patients who experienced allergic reactions after completing oral immunotherapy.
2.Rate of patients who used adrenaline self-injector.
3.Consumption frequency of tolerated foods.
4.Consumption of tolerated foods with or without reluctance.
5.Consumption of tolerated foods and allergic reactions experienced at school.

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021042

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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