UMIN-CTR Clinical Trial

Basic information
Public title	Effect of anti-histamine and oral corticosteroid for symptoms in oral food challenge
Acronym	Anti-histamine and oral corticosteroid for symptoms in OFC
Scientific Title	Effect of anti-histamine and oral corticosteroid for symptoms in oral food challenge
Scientific Title:Acronym	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	1st name Kyohei Middle name Last name Takahashi
Organization	National Hospital Organizaion Sagamihara Hospital
Division name	Department of Pediatrics
Zip code	2520315
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	1st name Kyohei Middle name Last name Takahashi
Organization	National Hospital Organizaion Sagamihara Hospital
Division name	Department of Pediatrics
Zip code	2520315
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)

IRB Contact (For public release)
Organization	Sagamihara National Hospital Ethical Committee
Address	Sakuradai 18-1, Minami-ward, Sagamihara city, Kanagawa pref., Japan
Tel	042-742-8311
Email	NoPublicEmailAddress@example.com

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

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	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 28 Day
Date of IRB	2017 Year 07 Month 04 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 01 Day
Last modified on	2021 Year 02 Month 01 Day

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