UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034016
Receipt number R000038783
Scientific Title The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study
Date of disclosure of the study information 2018/09/03
Last modified on 2020/09/08 00:27:36

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Basic information

Public title

The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study

Acronym

STABILITY study

Scientific Title

The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study

Scientific Title:Acronym

STABILITY study

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The investigation of remission maintenance therapy by mesalazine enema for the efficacy and safety after remission induction by budesonide form enema in patients with ulcerative colitis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Steroid-free endoscopic mucosal healing at week 48 after randomized allocation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema

Interventions/Control_2

The continuation of concomitant treatment at the remission induction by budesonide form enema (control 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: The patients with ulcerative colitis who were diagnosed according to the diagnostic criteria of the Research Committee on Inflammatory Bowel Disease in Japan
2: The patients with ulcerative colitis who were induced remission by the treatment of budesonide form enema (4 or more than 4 weeks)

Key exclusion criteria

1: The patients who are intolerant for mesalazine
2: The patients who were seemed to perform remission maintenance therapy by mesalazine enema at least 2 times per week during 48 weeks with stability
3: The patients who are difficult to perform 2 times total colonoscopy at the achievement of remission induction by budesonide form enema and week 48
4: The patients who are treated with only budesonide form enema at the randomization
5: The patients who had history of treatment with biologics or JAK inhibitor. However, the patients who were administrated with stable dose more than 6 months or withdrawn more than 4 months before can be enrolled.
6: The patients who were changed the dosage of concomitant immunomodulator within 3 months prior to registration
7: The patients who were changed the dosage of concomitant 5-aminosalicylate within 4 weeks prior to registration
8: The patients who were administrated steroid except budesonide form enema within 4 weeks prior to registration
9: The patients who are treated with topical 5-aminosalicylate (enema or suppository) at the registration. However, the patients who were withdrawn for the topical 5-aminosalicylate (enema or suppository) at the registration can be enrolled.
10: The patients who were indicated the lesion (1 or more than 1 of Mayo endoscopic subscore) at the proximal to splenic flexure by total colonoscopy after remission induction by budesonide form enema.
11: The patients who are treated with cytapheresis
12: The patients who were judged as unsuitable participant for registration of this study by physician

Target sample size

84


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Watanabe

Organization

Hyogo College of Medicine

Division name

Department of Intestinal Inflammation Research

Zip code

663-8501

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6663

Email

ke-watanabe@hyo-med.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Watanabe

Organization

Hyogo College of Medicine

Division name

Department of Intestinal Inflammation Research

Zip code

663-8501

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6663

Homepage URL


Email

ke-watanabe@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine, Center for Clinical Research and Education

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

The ethical committee of Hyogo College of Medicine

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

Tel

0798-45-6066

Email

rinri@hyo-med.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 09 Month 03 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

Terminated

Date of protocol fixation

2018 Year 07 Month 13 Day

Date of IRB

2018 Year 10 Month 25 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2021 Year 05 Month 13 Day

Date of closure to data entry

2021 Year 05 Month 13 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2020 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name