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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034016
Receipt No. 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 2018/09/03

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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
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
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
Middle name
Last name Kenji Watanabe
Organization Hyogo College of Medicine
Division name Department of Intestinal Inflammation Research
Zip code
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
Middle name
Last name Kenji Watanabe
Organization Hyogo College of Medicine
Division name Department of Intestinal Inflammation Research
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.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


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