UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017856 |
|---|---|
| Receipt number | R000020690 |
| Scientific Title | Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2018/06/12 14:06:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease
Acronym
Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease
Scientific Title
Multicenter research study on therapeutic efficacy and prognosis of inflammatory bowel disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takanari Kitazono |
Organization
Kyushu university
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-1151
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Nagata |
Organization
Kyushu university
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-1151
Homepage URL
youtka@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 07 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020690
