UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051334 |
|---|---|
| Receipt number | R000058563 |
| Scientific Title | Ehime Ulcerative Colitis Study |
| Date of disclosure of the study information | 2023/06/18 |
| Last modified on | 2023/06/13 18:48:51 |
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Basic information
Public title
Ehime Ulcerative Colitis Study
Acronym
Ehime Ulcerative Colitis Study
Scientific Title
Ehime Ulcerative Colitis Study
Scientific Title:Acronym
Ehime UC Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to find the factors for clinical outcomes in patients with ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
Mucosal healing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mucosal healing, clinical remission, sleep disorders, depression, sexual dysfunction, constipations, functional dyspepsia, use of biologics, and use of steroid
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who can understand the purpose of this study
Key exclusion criteria
Nothing special
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910924
Address
Toon, Ehime
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Furukawa |
Organization
Ehime University
Division name
Health Services Centor
Zip code
790
Address
3, Bunkyo, Matsuyama, Ehime
TEL
0899279198
Homepage URL
shinya.furukawa@gmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Shinya Furukawa
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-9605172
rinri@m.ehime-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 18 | 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
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
| 2015 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2035 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058563
