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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031556
Receipt No. R000035863
Scientific Title Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Date of disclosure of the study information 2018/03/02
Last modified on 2019/06/24

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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