|
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-UMIN000005358 |
|
Date of registration:
|
01/04/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Rapid LeukocyAPheresis InDuction for Ulcerative Colitis
|
|
Scientific title:
|
Rapid LeukocyAPheresis InDuction for Ulcerative Colitis - RAPID-UC |
|
Date of first enrolment:
|
2011/04/01 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006360 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase II,III
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
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 Lower GI disease |
|
|
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 Lower GI disease |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1) Patients with proctitis 2) Patients with chronic persistent UC 3) Patients having consecutively received corticosteroids therapy of 5mg/day or more, for more than 3 months 4) Patients having consecutively received corticosteroids enema therapy for more than 3 months 5) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3 6) Patients who are younger than 12 years old or who are older than 80 years old. 7) Patients determined to be inappropriate for this study by the investigators
Age minimum:
12years-old
Age maximum:
81years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
ulcerative colitis
|
|
Intervention(s)
|
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.
|
|
Primary Outcome(s)
|
|
The primary outcome is the improvement of Mayo score obtained after 6th LCAP. Mayo score is taken before (within 2 weeks of starting LCAP) and after 6th LCAP. Partial-Mayo score is taken at every visit and/or whenever the score has to be taken without endoscopic evaluation.
|
|
Secondary Outcome(s)
|
|
The secondary outcome is the Lichtiger's clinical activity index taken before (within 2 weeks of starting LCAP) and after 6th LCAP.
|
|
Source(s) of Monetary Support
|
|
Lower Gastroenterology, Hyogo College of Medicine
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|