UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003785 |
|---|---|
| Receipt number | R000004579 |
| Scientific Title | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2014/05/08 15:08:43 |
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Basic information
Public title
Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.
Acronym
A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis.
Scientific Title
Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy.
Scientific Title:Acronym
A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of 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 efficacy and safety of tacrolimus on remission maintenance in ulcerative colitis patients who are intolerant of azathioprine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Remission rate at 12 weeks after the start of protocol treatment
(Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
Key secondary outcomes
Evaluation of efficiency: Remission ratios at 24 and 48 weeks after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the Lichtiger's CAI and the Mayo's DAI, Dosage of concomitant steroid, etc.
Evaluation of safety: Occurrences of adverse event, abnormal values in blood test, and so on.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5-aminosalicylic acid monotherapy arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).
Interventions/Control_2
5-aminosalicylic acid monotherapy and tacrolimus arm:
5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule.
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
1. A patient who is diagnosed as ulcerative colitis.
2. A patient who has been induced to remission with tacrolimus and has been administered tacrolimus about 3 months.
3. A patient who is expected to suffer from severe adverse effect of azathioprine by reason of his (her) past history or other. (judged by a doctor in charge)
4. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement. (If a patient is under 20 years old, a signature of his (her) legal representative is necessary.)
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
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Nakamura |
Organization
Hyogo College of Medicine
Division name
Department of Internal medicine, Division of Lower Gastroenterology
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL
0798-45-6660
shiro@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Fukunaga |
Organization
Hyogo College of Medicine
Division name
Department of Internal medicine, Division of Lower Gastroenterology
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL
0798-45-6662
Homepage URL
kebe@hyo-med.ac.jp
Sponsor or person
Institute
Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 19 | Day |
Last modified on
| 2014 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004579
