UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007406 |
|---|---|
| Receipt number | R000008730 |
| Scientific Title | Clinical and endoscopic evaluation of the therapeutic effect of Tacrolimus with rapid dose reduction of steroid for ulcerative colitis |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2012/02/29 15:26:41 |
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Basic information
Public title
Clinical and endoscopic evaluation of the therapeutic effect of Tacrolimus with rapid dose reduction of steroid for ulcerative colitis
Acronym
Treatment with Tacrolimus for ulcerative colitis with rapid dose reduction of steroid
Scientific Title
Clinical and endoscopic evaluation of the therapeutic effect of Tacrolimus with rapid dose reduction of steroid for ulcerative colitis
Scientific Title:Acronym
Treatment with Tacrolimus for ulcerative colitis with rapid dose reduction of steroid
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of theraputic effect of Tacrolimus for ulcerative colitis with a rapid steroid withdrawal protocol and verify its usefulness
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mayo Score
Key secondary outcomes
Stool frequency,rectal bleeding, Matts Score, CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
conventional steroid tapering (5mg/day every 2 weeks)
Interventions/Control_2
rapidly tapering dose of steroid
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with relapsing ulcerative colitis with moderate to severe disease activity who admitted to Jichi Medical University hospital for induction of remission
In cases with co-morbid disease or infection, the patients' condition should be stable and no changes in the therapeutic regimen for the co-morbid diseases are expected
Patients who gave written informed consent for this study
Key exclusion criteria
Patients who are considered not suitable for Taclorimus use due to contraindication or considerable risks such as hypersensitivity to Tacrolimus
When a written informed consent cannot be obtained from the patients because of some memory disorders such as dementia
Other than above mentioned criteria, patients who are judged inappropriate by the chef study conductor or doctor in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Sato |
Organization
Jichi Medical University Hospital
Division name
Endoscopy Center
Zip code
Address
329-0498 3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL
0285-58-7539
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Sato |
Organization
Jichi Medical University Hospital
Division name
Endoscopy Center
Zip code
Address
329-0498 3311-1 Yakushiji Shimotsuke-shi Tochigi-ken
TEL
0285-58-7539
Homepage URL
hiro55@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Endoscopy Center
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
Address
Tel
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 29 | Day |
Last modified on
| 2012 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008730
