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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007406
Receipt No. 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

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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
Email

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
Email hiro55@jichi.ac.jp

Sponsor
Institute Jichi Medical University Hospital
Endoscopy Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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