UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005270
Receipt No. R000006268
Scientific Title Evaluation of optimal 5ASA dose in order to determine for keeping remission of patients with ulcerative colitis by colonoscopy using FICE (flexible spectral imaging color enhancement) system.
Date of disclosure of the study information 2011/04/01
Last modified on 2018/01/02

* 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 Evaluation of optimal 5ASA dose in order to determine for keeping remission of patients with ulcerative colitis by colonoscopy using FICE (flexible spectral imaging color enhancement) system.
Acronym Determination of optimal 5ASA dose for keeping remission of UC patients by FICE colonoscopy
Scientific Title Evaluation of optimal 5ASA dose in order to determine for keeping remission of patients with ulcerative colitis by colonoscopy using FICE (flexible spectral imaging color enhancement) system.
Scientific Title:Acronym Determination of optimal 5ASA dose for keeping remission of UC patients by FICE colonoscopy
Region
Japan

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

Objectives
Narrative objectives1 To determine the optical 5ASA dose to keep remission in patients with ulceraitive colitis by FICE magnifing colonoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes non-relapse rate by CAI score after one year
Key secondary outcomes clinical Activity Index (CAI)
vascular grading (VG)
vascular score (VS)
non-relapse rate after 3,6,9 months
inflammatory response score(WBC, Plt, ESR, CRP)
pathological Matts gradings
safety
remission period (month)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 GroupA:Pentasa4g/day or Asacol 3.6g/day (VS>5),same dose
Interventions/Control_2 GroupB:Pentasa4g/day or Asacol 3.6g/day (VS=5),same dose
Interventions/Control_3 GroupC:Pentasa4g/day or Asacol 3.6g/day (VS=5), decrease dose to Pentasa3g/day or Asacol 2.4g/day
Interventions/Control_4 GroupD:Pentasa2-3g/day or Asacol 2.4g/day (VS>5), same dose
Interventions/Control_5 GroupE:Pentasa2-3g/day or Asacol 2.4g/day (VS>5), increase dose to Pentasa4g/day or Asacol 3.6g/day
Interventions/Control_6 GroupF:Pentasa2-3g/day or Asacol 2.4g/day (VS=5),same dose
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 with quiescent ulcerative colitis who can accept colonoscopy
Patients whose CAI is 3 or less
Patients who takes mesalazine
Key exclusion criteria Patients who cannot accept colonoscopy
Patients who have no agreement of this study
Patients who is pregnant or possibly be pregnant
Patients who had operation of total or partial colectomy
Patients who got to start to take treamtents such as;
-sterids (intravenous, peroral, enema and suppo) within 4 weeks
-metrinidazole within 4 weeks
-infliximab within 4 weeks
-elemental diet or IVH within 4 weeks
-cyclosporine or tacrolimus within 4 weeks
-azathiopurine or 6MP within 4 weeks
-mesalazine enema or suppo within 4 weeks
-increase or decrease the mesalazine dose within 4 weeks
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 kamoda, Kawagoe City, Saitama, Japan
TEL 049-228-3564
Email skato@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo kato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 kamoda, Kawagoe City, Saitama, Japan
TEL +81-49-228-3564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Other
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
2011 Year 04 Month 01 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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 17 Day
Last modified on
2018 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006268

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.