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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-UMIN000010127
Date of registration:	01/04/2013
Prospective Registration:	Yes
Primary sponsor:	Department of Gastroenterology and Hepatology, Kyoto University Hospital
Public title:	Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis
Scientific title:	Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis - Mucosal concentration of 5-ASA by once-daily vs conventional dosing
Date of first enrolment:	2013/09/24
Target sample size:	50
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011862
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Minoru Matsuura
Address:	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan Japan
Telephone:	075-751-4319
Email:	minomats@kuhp.kyoto-u.ac.jp
Affiliation:	Kyoto University Hospital Department of Gastroenterology and Hepatology

Name:	Minoru Matsuura
Address:	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan Japan
Telephone:	075-751-4319
Email:	minomats@kuhp.kyoto-u.ac.jp
Affiliation:	Kyoto University Hospital Department of Gastroenterology and Hepatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with severe active or fulminant ulcerative colitis 2) Patients who received total or subtotal colectomy 3) Patients with malignancy 4) Patients who are pregnant or have the possibility of pregnancy 5) Patients whom investigators and subinvestigators considered to be inappropriate to participate in this study

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

ulcerative colitis

Intervention(s)

Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks

Primary Outcome(s)

Mucosal concentration of 5-ASA in the Rectum

Secondary Outcome(s)

Mucosal concentration of Ac-5-ASA in the rectum

Secondary ID(s)

Source(s) of Monetary Support

None

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/2016
URL:

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