|
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-UMIN000010906 |
|
Date of registration:
|
10/06/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission.
|
|
Scientific title:
|
The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. - Asacol4.8 maintenance |
|
Date of first enrolment:
|
2013/06/10 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012720 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase II
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
1-8-1 Inohana Chuo-Ku Chiba city
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chiba University Hospital Division of Gastroenterology |
|
|
Name:
|
Tomoo Nakagawa |
|
Address:
|
1-8-1 Inohana Chuo-Ku, Chiba city
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chiba University Hospital Division of Gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1) Patients who took mesalazine enema or salazopyrine suppository in 2 weeks before the day of the registration for this study 2) Patients who took steroid fomula in 1 month before that day 3) Patients who started to take immunomodulators or to escalate the dose of the medicine before that day. In addition, the patients who took the drug more than 90 days without dose-escalation are not excluded. 4) Patients who started to take anti-TNFa therapy before that day. In addition, the patients who took the therapy more than 90 days are not excluded. 5) Patients who took cytapheresis in 2 weeks before that day. 6) Patients who took antidiarrheal or antispasmodic drugs after screening examination. 7) Patients who used nicotine patch, received antibiotics and any product containing omega-3 fatty acids within the last 7 days. 8) Patients who is participated other clinical trials. 9) Patients who have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the deylayed-release mesalazine tablets. 10) Patients who have a history of serious adverse event to mesalazine. 11) Patients who have renal or hepatic diseases. 12) Patients whose stool examination positive for Clostridium difficile, bacterial pathogens, or ova and parasites. 13) Patients who have a history of alcohol abuse. 14) Patients who were diagnosed malignant neoplasms. 15) Patients who were pregnant and/or lactating women. 16) Patients who are having an effect of the adverse event by an investigational new drug (or a drug in Phase IV) in other clinical trial previously. 17) Patients who were considered unsuitable for this study by participant doctors.
Age minimum:
15years-old
Age maximum:
70years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
A 24-week administration of 4.8g/day of Asacol
A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy
|
|
Primary Outcome(s)
|
|
Clinical response rate at week 24 by UCDAI score
|
|
Source(s) of Monetary Support
|
|
Chiba University Hospital
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|