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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014275
Receipt No. R000016630
Scientific Title Efficacy of infliximab for refractory pouchitis with complexed anal fistula
Date of disclosure of the study information 2014/06/24
Last modified on 2015/12/17

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Basic information
Public title Efficacy of infliximab for refractory pouchitis with complexed anal fistula
Acronym Efficacy of infliximab for pouchitis with anal fistula
Scientific Title Efficacy of infliximab for refractory pouchitis with complexed anal fistula
Scientific Title:Acronym Efficacy of infliximab for pouchitis with anal fistula
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pouchitiswith anal fistula after restorative proctocolectomy is the major complication which could be resulted in pouch failure. The aim of this study is to evaluate the efficacy of infliximab therapy for pouchitis with anal fistula.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Assesment of healing rate of fistula and avoiding rate of re-ileostomy due to pouch failure.
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 infliximab
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 pouchitis with anal fistula
Key exclusion criteria Diagnosed with Crohn's disease or its suspiciousness
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo Colllege of Medicine
Division name Department of Inflammatory Bowel Disease
Zip code
Address 1-1,Mukogawacho,Nishinomiya,Hyogo,Japan
TEL 0798-45-6371
Email uchino2s@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease
Zip code
Address 1-1,Mukogawacho,Nishinomiya,Hyogo,Japan
TEL 0798-45-6371
Homepage URL
Email uchino2s@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Outside Japan
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
2014 Year 06 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 16 Day
Last modified on
2015 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016630

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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