UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014275
Receipt number 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 07:39:58

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.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