|
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-UMIN000013033 |
|
Date of registration:
|
01/02/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.
|
|
Scientific title:
|
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. - Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis |
|
Date of first enrolment:
|
2014/02/01 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Pending |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015211 |
|
Study type:
|
Interventional,observational |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Taro Osada |
|
Address:
|
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
Japan |
|
Telephone:
|
0338133111 |
|
Email:
|
otaro@juntendo.ac.jp |
|
Affiliation:
|
Department of Internal Medicine,Juntendo University Department of Gastroenterology |
|
|
Name:
|
Taro Osada |
|
Address:
|
2-1-1 Hongo,Bunkyo ward,Tokyo,JapanTokyo Japan
Japan |
|
Telephone:
|
03-3813-3111 |
|
Email:
|
otaro@juntendo.ac.jp |
|
Affiliation:
|
Department of Internal Medicine,Juntendo University Department of Gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1. The patients with serious infection (sepsis) 2. The patients with active tuberculosis 3. The patients with a history of sensitivity to protein(mouse type, a chimeric type, humanized antibody) derived from a mouse or ingredient of the Infliximab 4. The patients with a history of demyelinating diseases (Multiple sclerosis) 5. The patients with congestive heart failure 6. The patients that doctor attending judged an arrangement to this study to be inappropriate
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative colitis
|
|
Intervention(s)
|
|
Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)
|
|
Primary Outcome(s)
|
|
Mayo score percent improvement 6-14 weeks after the administration.
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|