UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009815 |
|---|---|
| Receipt number | R000011489 |
| Scientific Title | Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2019/02/08 05:32:18 |
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Basic information
Public title
Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Acronym
Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Scientific Title
Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Scientific Title:Acronym
Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Region
| Japan |
Condition
Condition
eosinophilic esophagitis
bronchial asthma
Classification by specialty
| Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the prevalence rate of the eosinophilic esophagitis among the patients with bronchial asthma and the risk factors of developing the disease
Basic objectives2
Others
Basic objectives -Others
prevalence rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
prevalence rate of the eosinophilic esophagitis among the patients with bronchial asthma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
gastrointestinal fiberscopy
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 with bronchial asthma diagnosed by pulmonary physician.
written informed concent.
Key exclusion criteria
receiving systemic glucocorticoids.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane university faculty of medicine
Division name
second department of internal medicine
Zip code
Address
89-1, Ennya-Cho, Izumo, Shimane, 693-8501, Jpan
TEL
+81-853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane university faculty of medicine
Division name
second department of internal medicine
Zip code
Address
89-1, Ennya-Cho, Izumo, Shimane, 693-8501, Jpan
TEL
+81-853-20-2190
Homepage URL
kinosita@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane universitu faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane university facutly of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Matsue Red Cross Hospital
Matsue City Hospital
Hamada medical center
Yonago medical center
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
Shimane university Hospital (Shimane)
Matsue Red Cross Hospital (Shimane)
Matsue City Hospital (Shimane)
Hamada medical center (Shimane)
Yonago medical center (Tottori)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011489
