UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031556
Receipt number 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 11:56:17

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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 or person

Institute

Keio University

Institute

Department

Personal name



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

Value
https://center6.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