UMIN-CTR Clinical Trial

Basic information
Public title	The prevalence and disease conditions of mesalazine intolerance in inflammatory bowel disease: Multicenter retrospective observational study
Acronym	The investigation for mesalazine intolerance in patients with inflammatory bowel disease
Scientific Title	The prevalence and disease conditions of mesalazine intolerance in inflammatory bowel disease: Multicenter retrospective observational study
Scientific Title:Acronym	The investigation for mesalazine intolerance in patients with inflammatory bowel disease
Region	Japan

Condition
Condition	Inflammatory bowel diseasa
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the prevalence and disease conditions of mesalazine intolerance in inflammatory bowel disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence rate of mesalazine intolerance in IBD patients according to the time of disease onset
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Outpatients and inpatients (UC or CD, IBD-unclassified and intestinal Behcet's disease) at Okayama University hospital and the research institutions betwee January 2016 and December 2016 2.Patients with the past or current history of mesalazine therapy 3.Patients whose disease courses after mesalazine administration can be examined through in the medical records
Key exclusion criteria	Patients who refused the participation in this study due to the published information
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sakiko Hiraoka
Organization	Okayama University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Email	sakikoh@cc.okayama-.u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sakiko Hiraoka
Organization	Okayama University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Homepage URL
Email	sakikoh@cc.okayama-.u.ac.jp

Sponsor
Institute	Okayama University Graduate School of medicine
Institute
Department

Funding Source
Organization	None
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 11 Month 11 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	Completed
Date of protocol fixation	2017 Year 11 Month 11 Day
Date of IRB	2017 Year 10 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 11 Day
Last follow-up date	2020 Year 01 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	OGUTs

Management information
Registered date	2017 Year 09 Month 28 Day
Last modified on	2021 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033530