UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000029338
Receipt number 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 2021/05/08 17:02:20

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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 or person

Institute

Okayama University Graduate School of medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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