UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031016 |
|---|---|
| Receipt number | R000035414 |
| Scientific Title | Efficacy and safety of local budesonide for pouchitis |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2023/08/01 16:01:00 |
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Basic information
Public title
Efficacy and safety of local budesonide for pouchitis
Acronym
Efficacy of budesonide for pouchitis
Scientific Title
Efficacy and safety of local budesonide for pouchitis
Scientific Title:Acronym
Efficacy of budesonide for pouchitis
Region
| Japan |
Condition
Condition
ulcerative colitis
pouchitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pouchitis can be developed even after colectomy in patients with ulcerative colitis. Although the oral antibiotics has efficacy for pouchitis, additional treatments which include immunosupressive therapies are often required. Therefore, I invastigate the efficacy and safety of local budesonide for pouchitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Improving rate of pouchitis after treatment with local budesonide.
Key secondary outcomes
Safety
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with diagnosisi of pouchitis by using modified pouchitis disease activity index.
Key exclusion criteria
under 20 years old or over 70 years old.
Patients without agreement.
Patients who are treated with another concomitant immunosupressive treatments.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motoi |
| Middle name | |
| Last name | Uchino |
Organization
Hyogo College of Medicine
Division name
Department of Inflammatory Bowel disease
Zip code
6638501
Address
Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6371
uchino2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Uchino |
Organization
Hyogo College of Medicine
Division name
Department of Inflammatory Bowel Disease
Zip code
6638501
Address
Mukogawa-cho 1-1, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6371
Homepage URL
uchino2s@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Department of Inflammatory Bowel Disease
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1Mukogawacho Nishinomiya
Tel
0798456371
uchino2s@hyo-med.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
| 2018 | Year | 02 | Month | 15 | 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
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The informations of efficacy and safety during local budesonide treatment in patients with pouchitis will be collect prospectively.
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035414
