UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005824 |
|---|---|
| Receipt number | R000006887 |
| Scientific Title | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2013/12/24 12:31:06 |
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Basic information
Public title
Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis
Acronym
Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis
Scientific Title
Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis
Scientific Title:Acronym
Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate 1)clinical efficacy and 2)occurrences of adverse event of tacrolimus on treatment in outpatients with moderate to severe ulcerative colitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical and endoscopic remission rate at 12 weeks after the start of protocol treatment
Key secondary outcomes
Achievement rate of the target trough levels (7 to 12 ng/mL) of the blood trough concentrations of tacrolimus at 1 and 2 weeks after start of protocol treatment
Correlation between the blood trough concentrations of tacrolimus and efficacy at 1 and 2 weeks after start of protocol treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tacrolimus (12weeks)
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient who is diagnosed as moderate and severe ulcerative colitis.
A patient who is able to receive outpatient care.
Key exclusion criteria
1. A patient who has had hypersensitivity to tacrolimus or ingredients of tacrolimus formulation.
2. A patient who is in treatment of cyclosporine or bozentan.
3. A patient who is in treatment of potassium sparing diuretics.
4. A patient who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period.
5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku,Tokyo
TEL
03-3813-3111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
otaro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 21 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006887
