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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003785
Receipt No. 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

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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
Email 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
Email kebe@hyo-med.ac.jp

Sponsor
Institute Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004579

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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