UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease
Title of the study (Brief title)	Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease
Region	Japan

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

Objectives
Narrative objectives1	To establish appropriate therapeutic method and examination in inflammatory bowel disease patients as to research clinical course
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of each therapeutic methods, long-term prognosis, etiology and clinical state in inflammatory bowel disease patients
Key secondary outcomes	Risk factors about complication, exacerbation, developing malignant tissue and loss of response to biologics

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	Patients diagnosed inflammatory bowel disease in kyushu university hospital and associated facilities
Key exclusion criteria	Patients who disagree this study
Target sample size	1850

Research contact person
Name of lead principal investigator	Takanari Kitazono
Organization	Kyushu university
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-1151
Email	kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Yutaka Nagata
Organization	Kyushu university
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-1151
Homepage URL
Email	youtka@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	MHLW(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 07 Day
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective and retrospective study

Management information
Registered date	2015 Year 06 Month 10 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020690