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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029338
Receipt No. R000033530
Scientific Title The prevalence and disease conditions of mesalazine intolerance in inflammatory bowel disease: Multicenter retrospective observational study
Date of disclosure of the study information 2018/11/11
Last modified on 2017/10/03

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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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information OGUTs

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2017 Year 10 Month 03 Day


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

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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