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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033584
Receipt No. R000037811
Official scientific title of the study Effect of anti-histamine and oral corticosteroid for symptoms in oral food challenge
Date of disclosure of the study information 2018/08/02
Last modified on 2018/08/02

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Basic information
Official scientific title of the study Effect of anti-histamine and oral corticosteroid for symptoms in oral food challenge
Title of the study (Brief title) Anti-histamine and oral corticosteroid for symptoms in OFC
Region
Japan

Condition
Condition food allergy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Anti-histamine and oral corticosteroid medications are widely used to treat acute allergic reaction symptoms. However, the effectiveness of anti-histamine and oral corticosteroid on induced-symptoms during oral food challenge (OFC) has not been clarified. We previously reported oral corticosteroid may shorten the time length of abdominal symptoms.
The aim of this study is to clarify prospectively whether anti-histamine and/or oral corticosteroid could shorten the duration of abdominal pain by double blind randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of abdominal pain (Assessed with Wong-Baker FACES Pain Rating Scale at least every 5 minutes)
Key secondary outcomes - Additional treatment (antihistamine, corticosteroid, adrenaline, Inhaled beta2-agonists)
- Duration of other symptoms

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Anti-histamine only
Interventions/Control_2 Oral corticosteroid only
Interventions/Control_3 Both anti-histamine and oral corticosteroid
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
1) who underwent inpatient OFC
2) who are 5 years old or older
3) who have abdominal pain when diagnosed as positive in OFC.
Key exclusion criteria Patients who require adrenaline administration in time of randomization.
Target sample size 80

Research contact person
Name of lead principal investigator Kyohei Takahashi
Organization National Hospital Organizaion Sagamihara Hospital
Division name Department of Pediatrics
Address Sakuradai 18-1, Minami-ward, Sagamihara city, Kanagawa pref., Japan
TEL 042-742-8311
Email kcrt@kcrt.net

Public contact
Name of contact person Kyohei Takahashi
Organization National Hospital Organizaion Sagamihara Hospital
Division name Department of Pediatrics
Address Sakuradai 18-1, Minami-ward, Sagamihara city, Kanagawa pref., Japan
TEL 042-742-8311
Homepage URL
Email kcrt@kcrt.net

Sponsor
Institute Department of Pediatrics, National Hospital Organizaion Sagamihara Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 独立行政法人国立病院機構相模原病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 02 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 28 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037811

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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