UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Shingo kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 kamoda, Kawagoe City, Saitama, Japan
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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