UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030000 |
|---|---|
| Receipt number | R000034256 |
| Scientific Title | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2021/11/19 13:44:27 |
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Basic information
Public title
The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Acronym
The efficacy and safety of topical budezonide for pouchitis.
Scientific Title
The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Scientific Title:Acronym
The efficacy and safety of topical budezonide for pouchitis.
Region
| Japan |
Condition
Condition
ulcerative colitis
pouchitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of topical budesonide for pouchitis in patients with ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The remission rate after 2weeks of treatment.
Key secondary outcomes
The change of pouchitis disease activity index score during 2weeks of treatment.
The rate of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical budesonido
2weeks of 2mg daily
Interventions/Control_2
Topical prednisolone
2weeks 20mg daily
Interventions/Control_3
Topical aminosalicylate
2weeks 1g daily
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 agreement.
Patients with pouchitis.
Key exclusion criteria
Patients without agreement.
Patients with drug allergy.
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
663-8501
Address
1-1 Mukogawacho, Nishinomiya, 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
663-8501
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6371
Homepage URL
uchino2s@hyo-med.ac.jp
Sponsor or person
Institute
Department of Inflammatory Bowel Disease
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Inflammatory Bowel Disease
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawacho Nishinomiya Hyogo
Tel
0798456371
motoi.uchino@nifty.ne.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
| 2017 | Year | 12 | 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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 16 | Day |
Last modified on
| 2021 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034256
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