UMIN-CTR Clinical Trial

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
Institute	Hyogo College of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038783