UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005270 |
|---|---|
| Receipt number | 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 21:37:53 |
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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
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
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006268
