|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000003785 |
|
Date of registration:
|
01/07/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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.
|
|
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. - A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis. |
|
Date of first enrolment:
|
2010/07/01 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004579 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase III
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Ken Fukunaga |
|
Address:
|
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
Japan |
|
Telephone:
|
0798-45-6662 |
|
Email:
|
kebe@hyo-med.ac.jp |
|
Affiliation:
|
Hyogo College of Medicine Department of Internal medicine, Division of Lower Gastroenterology |
|
|
Name:
|
Shiro Nakamura |
|
Address:
|
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
Japan |
|
Telephone:
|
0798-45-6660 |
|
Email:
|
shiro@hyo-med.ac.jp |
|
Affiliation:
|
Hyogo College of Medicine Department of Internal medicine, Division of Lower Gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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.
Age minimum:
16years-old
Age maximum:
65years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative colitis
|
|
Intervention(s)
|
5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks).
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.
|
|
Primary Outcome(s)
|
|
Remission rate at 12 weeks after the start of protocol treatment (Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)
|
|
Secondary Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
None
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/06/2013 |
|
URL:
|
|
|
|