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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002796
Receipt No. R000002658
Scientific Title Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
Date of disclosure of the study information 2009/11/25
Last modified on 2013/12/29

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Basic information
Public title Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
Acronym Clinical trial of tacrolimus for patients with Crohn's disease
Scientific Title Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
Scientific Title:Acronym Clinical trial of tacrolimus for patients with Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy and safty of tactolimus therapy in patiets with active Crohn's disease refractory to or intolerant of azathioprine(6-MP) and /or inflixmab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Crohn's disease activity index at 0.4.8 weeks after treatment
Key secondary outcomes (1)change of CRP
(2)percentage of patients achieved remission after treatment
(3)safty
(4)percentage of pateints with decreasing more than 100 points of CDAI after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks.
For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml).
Interventions/Control_2 placebo control
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 220 < CDAI <450
Key exclusion criteria (1)patients with severe active disease-massive bleeding case, perforating case(2)patients with severe cardiac disease, liver disease, respiratory disease
(3)patients with renal disease and hyperkalemia
(4)patients with malignant disease, history of malignancy
(5)patients with severe infection
(6)patient having pregnancy or having the possiblity of pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiba Tsutomu
Organization Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyoku, Kyoto
TEL 075-751-4319
Email chiba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nakase
Organization Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyoku, Kyoto
TEL 075-751-4319
Homepage URL
Email hiropy_n@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kyoto University
Institute
Department

Funding Source
Organization the Ministry of Health, Labor, and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 25 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
2009 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 12 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
2009 Year 11 Month 24 Day
Last modified on
2013 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002658

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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