UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033584 |
|---|---|
| Receipt number | R000037811 |
| Scientific Title | 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 | 2021/02/01 18:39:25 |
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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
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
kcrt@kcrt.net
Sponsor or person
Institute
Department of Pediatrics, National Hospital Organizaion Sagamihara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
