UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032377 |
|---|---|
| Receipt number | R000034828 |
| Scientific Title | Esophageal motility disorders caused by esophageal eosinophilia |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2022/10/27 20:54:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Esophageal motility disorders caused by esophageal eosinophilia
Acronym
Esophageal motility disorders by eosinophil infiltration
Scientific Title
Esophageal motility disorders caused by esophageal eosinophilia
Scientific Title:Acronym
Esophageal motility disorders by eosinophil infiltration
Region
| Japan |
Condition
Condition
Esophageal motility disorders
Eosinophilic esophagitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the esophageal motility in the patients with eosinophilic esophagitis , the impact of eosinophil infiltration on primary esophageal motility disorders, thus we will find the useful knowledge for the strategy to choose the best treatment for the patients with esophageal motility disorders
Basic objectives2
Others
Basic objectives -Others
Pathophysiological investigation
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of esophageal motility disorders in the patients with eosinophilic infiltration into esophageal mucosa
Key secondary outcomes
The prevalence of eosinophil infiltration among eosinophilic esophagitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent both esophageal manometry and endoscopic biopsy to determine eosinophil infiltration in esophageal mucosa
Key exclusion criteria
None
Target sample size
306
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Uraoka |
Organization
Gunma University Hospital
Division name
Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
0272208137
uraoka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hosaka |
Organization
Gunma University Hospital
Division name
Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8137
Homepage URL
hhosaka@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-22Showa-machi
Tel
0272208137
hitotaisho-ciru@ml.gunma-u.ac.jp
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
群馬大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Unpublished
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034828
