UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021896 |
|---|---|
| Receipt number | R000025252 |
| Scientific Title | Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis |
| Date of disclosure of the study information | 2016/04/13 |
| Last modified on | 2020/10/19 17:55:10 |
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Basic information
Public title
Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Acronym
Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Scientific Title
Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Scientific Title:Acronym
Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcernative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early efficacy and safety of tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy rate after 12 weeks(partial DAI score and Lichtiger score)
Key secondary outcomes
1, Remission rate after 12 weeks
2, DAI score and Lichtiger score after 12 weeks
3, Endoscopic remission rate after 12 weeks(mucosal healing)
4, The condition of reactivation(Presence or absence of reactivation and time to reactivation)
5, Safety(Presence or absence of adverse eventes and abnormality of laboratory values)
6, Efficacy of steroid taper
7, Influences efficacy of factor for patient background and therapy
8, Relationship with gene polymorphism of CYP3A5 and efficacy of tacrolimus and trough levels
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 with moderate to severe ulcerative colitis
Key exclusion criteria
Patients who contraindicate for tacrolimus. Patients who contraindicate for tacrolimus.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Matsui |
Organization
Fukuoka University Chilushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
Zokumyouin 1-1-1, Chikushino, Fukuoka
TEL
092-921-1011
matsui@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumihito |
| Middle name | |
| Last name | Hirai |
Organization
Fukuoka University Chilushi Hospital
Division name
Department of Gastroenterology
Zip code
818-8502
Address
Zokumyouin 1-1-1, Chikushino, Fukuoka
TEL
092-921-1011
Homepage URL
fuhirai@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chilushi Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
Zokumyouin 1-1-1, Chikushino, Fukuoka
Tel
092-921-1011
syokaki@fukuoka-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
| 2016 | Year | 04 | Month | 13 | 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
| 2014 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Early efficacy and safety of tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis.
Management information
Registered date
| 2016 | Year | 04 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
