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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025778
Receipt No. R000029555
Scientific Title Prospective cohort study of corticosteroids for inflammatory bowel disease
Date of disclosure of the study information 2017/01/22
Last modified on 2018/07/31

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Basic information
Public title Prospective cohort study of corticosteroids for inflammatory bowel disease
Acronym Prospective cohort study of corticosteroids for inflammatory bowel disease
Scientific Title Prospective cohort study of corticosteroids for inflammatory bowel disease
Scientific Title:Acronym Prospective cohort study of corticosteroids for inflammatory bowel disease
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness evaluation of PSL for inflammatory bowel disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rates of 8 weeks after corticosteroids
Key secondary outcomes Response rates at 30 weeks and 54 weeks after corticosteroids
Remission rates at 8, 30 weeks and 54 weeks after corticosteroids
The incidence of adverse events

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients of ulcerative colitis or Crohn disease
2)Partial Mayo score above2 or CDAI above149
3)with agreement
Key exclusion criteria 1)colitis other than ulcerative colitis or Crohn disease
2)patients who have symptomatic gastrointestinal stenosis
3)patients who destine to undergo colectomy
4)serious infectious disease
5)patients who investigators and subinvestigators consider to be inappropriate to participate in this study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Naganuma
Organization Keio University
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinano-machi, Shinjyu-ku , Tokyo
TEL 03-3353-1211
Email nagamakoto@z7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Mutaguchi
Organization Keio University
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinano-machi, Shinjyu-ku , Tokyo
TEL 03-3353-1211
Homepage URL
Email m.mutaguchi@keio.jp

Sponsor
Institute Keio University Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization self funing
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 01 Month 22 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2017 Year 01 Month 20 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029555

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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