UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Acronym	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Scientific Title	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Scientific Title:Acronym	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
Region	Japan

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

Objectives
Narrative objectives1	In this study, patients with ulcerative colitis in a fixed amount of time-dependent mesalazine granule preparation or orally administered pH-dependent mesalazine tablets underwent rectal examination by clinical findings, specimen examination, image examination, and lower endoscopic examination of periodic examination , Secondary utilization of biopsy tissue in the cecum to measure the concentration of 5-ASA and acetyl 5-ASA in the colonic mucosa and to compare the usefulness of time-dependent mesalazine granule preparation and pH dependent mesalazine tablet.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the concentrations of 5-ASA and acetyl 5-ASA in rectal, cecal biopsy tissue, remission induction rate / maintenance rate (Mayo 1 or less)
Key secondary outcomes	Drug efficacy rate (improvement of CAI by 30% or more), remission maintenance rate and duration, side effect occurrence rate, endoscopic findings, CRP, change amount of calprotectin in the stool

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .
Interventions/Control_2	PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with remission, mild or moderate ulcerative colitis (endoscopic Mayo score 2 or less, or less severe classification by Suzuki team of the Ministry of Health, Labor and Welfare) 2) Patients who aged 20 years or older at the time of acquiring consent. 3) Patients who have not changed the contents of medication to the original disease within the last 8 weeks of participation in this study. 4) Time-dependent mesalazine granule preparation 2.0 - 4.0 mg / day or pH dependent mesalazine tablet 2.4 - 4.8 mg / day Patients who received written informed consent.
Key exclusion criteria	1) People with severe or fulminant ulcerative colitis. (Mayo score 2 or less, or less severe classification by Suzuki team of Ministry of Health, Labor and Welfare) 2) Patients undergoing total colon resection, subtotal puncture surgery etc. 3) Patients with liver dysfunction and renal dysfunction. 4) Patients undergoing antithrombotic therapy or anticoagulant therapy and patients with thrombocytopenia. 5) Pregnant women or patients who may be pregnant, breast-feeding patients. 6) Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study. 7) Other patients who decided that the doctor in charge is inappropriate, such as a decline in compliance.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tnakanari Kitazono
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5261
Email	akharada@intmed2.med.kyushu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Akira Harada
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5261
Homepage URL	http://www.gut.med.kyushu-u.ac.jp/
Email	akharada@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Kyushu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Related information
URL releasing protocol	http://www.gut.med.kyushu-u.ac.jp/
Publication of results	Unpublished

Result
URL related to results and publications	http://www.gut.med.kyushu-u.ac.jp/
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	2017 Year 02 Month 17 Day
Date of IRB	2017 Year 02 Month 17 Day
Anticipated trial start date	2017 Year 06 Month 23 Day
Last follow-up date	2019 Year 03 Month 08 Day
Date of closure to data entry	2019 Year 03 Month 08 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030077