UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018075 |
|---|---|
| Receipt number | R000020924 |
| Scientific Title | Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2018/04/07 11:12:35 |
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Basic information
Public title
Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions
Acronym
Clinical trial for UC-AC
Scientific Title
Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions
Scientific Title:Acronym
Clinical trial for UC-AC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify middle to long-term prognosis of UC patients with clinical remission who have colonic active lesions and treat with optimized treatments
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of clinical maintenance of remission within 12 months after entry of the study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA
Interventions/Control_2
no optimized therapy
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 Patients have been diagnosed as definitive ulcerative colitis.
2 Patients with clinical remission (Partial Mayo is 0-2) in addition to Endoscopic Mayo score is 1-2.
3 Patients who agree to entry into this study.
4 Patients whose age is equal and more than 20 years-old.
Key exclusion criteria
Patients who can not distinct from other colitis, such as infectious colitis.
Patients who have any gastrointestinal stenosis.
Patients who were changed the dose of 5-ASA, or who received topical enema, or adalimumab within 2 weeks before the entry of study, or who received infliximab within 4 weeks before the entry of study.
Patients who received corticosteroids within 4 weeks before the entry of study.
Patients who received thiopurine, or tacrolimus, or cyclosporin within 8 weeks before the entry of study.
Patients who receive apheresis within 2 weeks before the entry of study.
Patients who will have plans to receive surgical treatments within 12 months after the entry of study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
School of Medicine, Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-KU Tokyo
TEL
81-3-3353-1211
maknaganuma@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
School of Medicine, Keio University
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address
35 Shinanomachi, Shinjuku-KU Tokyo
TEL
81-3-3353-1211
Homepage URL
maknaganuma@gmail.com
Sponsor or person
Institute
Center for Diagnostic and Therapeutic Endoscopy,Keio University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 26 | 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
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2018 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020924
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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