UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Acronym	Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Scientific Title	Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Scientific Title:Acronym	Clinical study of 5-ASA concentration in colonic mucosa for patients with ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigate relationship between colonic mucosa concentration of 5-ASA preparation and endoscopic disease activity level.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between 5-ASA concentration in colonic mucosa and colonic endoscopic activity
Key secondary outcomes	Correlation between 5-ASA concentration in colonic mucosa and clinical symptoms (Partial UCDAI, DAI, Lichtiger index)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Men and women aged 20 years and over. Patients diagnosed with mild or moderate ulcerative colitis. Patients scheduled to undergo colonoscopy. Patients taking at least 5-ASA preparation at the same dose for 8 weeks or more at the time of endoscopy Patients who can obtain consent to participate in the examination by document. Patients who the doctor admitted to participate in this study
Key exclusion criteria	Patients who have been 6 weeks or more past relapse diagnosis. Patients with poor medication adherence for 5-ASA drugs Cases using 5-ASA topical therapy (suppository, enema preparation) within 1 week of endoscopy Patient who used steroid formulation (suppository, enema, oral steroid formulation, steroid injectable formulation) or biologic formulation within 2 weeks of endoscopic enrollment. Patients with Crohn's disease or peptic ulcer Patients with history of colorectal surgery Patients with severe renal and liver impairment
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Makoto Middle name Last name Naganuma
Organization	Keio University
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	160-8582
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Email	maknaganuma@gmail.com

Public contact
1st name of contact person	1st name Makoto Middle name Last name Naganuma
Organization	Keio University
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	1608582
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Homepage URL
Email	nagamakoto@z7.keio.jp

Sponsor
Institute	Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department

Funding Source
Organization	MOCHIDA PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 09 Day
Date of IRB	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 02 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2018 Year 02 Month 10 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035669