UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002796 |
|---|---|
| Receipt number | 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 14:46:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiropy_n@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002658
