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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010115
Receipt No. R000011854
Scientific Title The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis
Date of disclosure of the study information 2013/02/28
Last modified on 2014/08/25

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Basic information
Public title The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis
Acronym Association of I-FOBT with UCCIS in quiescent ulcerative colitis patients
Scientific Title The utility of I-FOBT to predict relapsing inflammation in the patients with quiescent ulcerative colitis
Scientific Title:Acronym Association of I-FOBT with UCCIS in quiescent ulcerative colitis patients
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association of I-FOBT with UCCIS in quiescent ulcerative colitis patients and to evaluate the utility of I-FOBT to predict relapse as a noninvasive screening examination
Basic objectives2 Others
Basic objectives -Others The investigation of the efficacy of I-FOBT for the natural course of ulcerative colitis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between I-FOBT and UCCIS
Key secondary outcomes relapse rate and time to relapse

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Outpatients
2) Adult patients who have been diagnosed as ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on January 26, 2012)
3) Those who are diagnosed in the clinically remission stage (PGA=0)
4) Patients who were induced remission with SASP, mesalazine, steroid or immunomodulator and are maintained with those drugs
5) Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study
Key exclusion criteria 1) Patients who have received total / subtotal colectomy
2) Patients who have been complicated or have history with malignant tumor
3) Patients who were induced or maintained remission with biologics
4) Patients who needed dose-increase or addition of drug for maintenance of remission during study period
5) Patients who are pregnant or possibly pregnant
6) Other patients whom investigators and subinvestigators considered inappropriate to participate in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Homepage URL
Email takatomo@koto.kpu-m.ac.jp

Sponsor
Institute Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
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
2013 Year 02 Month 28 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 Completed
Date of protocol fixation
2013 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 28 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information To investigate the relationship between I-FOBT and endoscopic findings of the patients with ulcerative colitis in remission phase prospectively. The medication will be changed to 2g/day of 5-ASA.

Management information
Registered date
2013 Year 02 Month 25 Day
Last modified on
2014 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011854

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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