UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis
Title of the study (Brief title)	Mucosal concentration of 5-ASA by once-daily vs conventional dosing
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the mucosal concentration of 5-ASA by once-daily vs divided dosing in quiescent ulcerative colitis patients
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Mucosal concentration of 5-ASA in the Rectum
Key secondary outcomes	Mucosal concentration of Ac-5-ASA in the rectum

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks
Interventions/Control_2	Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks
Interventions/Control_3	Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Outpatients 2) Adult patients who have been in remission by the treatment with oral mesalazine 3) Patients who able provided written informed consent
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	Minoru Matsuura
Organization	Kyoto University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	075-751-4319
Email	minomats@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Minoru Matsuura
Organization	Kyoto University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	075-751-4319
Homepage URL
Email	minomats@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 17 Day
Anticipated trial start date	2013 Year 09 Month 24 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 26 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011862