UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018960 |
|---|---|
| Receipt number | R000021939 |
| Scientific Title | Study for making diagnosis criteria of pediatric allergis rhinitis |
| Date of disclosure of the study information | 2015/09/09 |
| Last modified on | 2018/07/05 05:32:12 |
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Basic information
Public title
Study for making diagnosis criteria of pediatric allergis rhinitis
Acronym
Study of pediatric allergic rhintis
Scientific Title
Study for making diagnosis criteria of pediatric allergis rhinitis
Scientific Title:Acronym
Study of pediatric allergic rhintis
Region
| Japan |
Condition
Condition
Allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the necessary items to diagnosis pediatric allergic rhinitis
Basic objectives2
Others
Basic objectives -Others
To examine the item which is not necessary for a diagnosis of pediatric allergic rhinitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the necessary items to diagnosis pediatric allergic rhinitis
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who consulted otolaryngology for nasal symptoms
Key exclusion criteria
Chilren who do not complain of nasal symptoms
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-226-2137
jibika@office.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Otolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku, Chiba, 260-8677
TEL
043-226-2137
Homepage URL
jibika@office.chiba-u.jp
Sponsor or person
Institute
Dept. of Otolaryngology, Graduate School of Medicine,
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 09 | 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 | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjecs are pediatric patients (<13 yr old) with rhinitis who consulted otolaryngologist in Chiba univ., Yamagata univ., Nippon medical school, Saitama medical school, Yamanasi univ., Nagoya municipal univ., Mie univ., Fukui univ., Okayama univ. and their associated institutions after November 2014.
The survey is conducted using a questionnarie.
Investigation items are symptoms, nasal findings, IgE and eosinophils in nasal smear, etc.
Management information
Registered date
| 2015 | Year | 09 | Month | 09 | Day |
Last modified on
| 2018 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021939
