UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Acronym	Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Scientific Title	Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Scientific Title:Acronym	Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Region	Japan

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

Objectives
Narrative objectives1	This study is performed to assess efficacy whether therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1 prevent disease relapse.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	disease relapse for 1 year.
Key secondary outcomes	Relationship between fecal calprotectin and relapse rate Relationship between UCEIS and relapse rate Relationship between dosage of 5ASA and relapse rate Contents of additional treatment after relapse Transition of pMayo during the observation period Relationship between adherence and relapse Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	therapeutic intervention group
Interventions/Control_2	observation group
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients were diagnosed as Ulcerative colitis. 2) Mayo Endoscopic score of 1 3) pMayo above 2 and rectal bleeding score of 0 4) Over 16years old and patients to obtain consent for this study.
Key exclusion criteria	Patients with colitis except for Ulcerative colitis. Patients with gastrointestinal obstruction. Preoperation patients. Patients with severe infection. Patients with malignancy or history of malignancy. Patients received anti TNF a antibody, tacrolimus or topical therapy. Inappropriate patients by doctor's judgement.
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Takanori Middle name Last name Kanai
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	takagast@z2.keio.jp

Public contact
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	160-8582
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Homepage URL
Email	maknaganuma@gmail.com

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee of Keio University
Address	35 Shinano-machi, Shinjyu-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 03 Month 02 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 02 Day
Date of IRB	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 02 Day
Last modified on	2019 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035863