UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031556 |
|---|---|
| Receipt number | R000035863 |
| Scientific Title | Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1. |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2019/06/24 11:56:17 |
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Basic information
Public title
Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Acronym
Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Scientific Title
Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Scientific Title:Acronym
Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is performed to assess efficacy whether therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1 prevent disease relapse.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
disease relapse for 1 year.
Key secondary outcomes
Relationship between fecal calprotectin and relapse rate
Relationship between UCEIS and relapse rate
Relationship between dosage of 5ASA and relapse rate
Contents of additional treatment after relapse
Transition of pMayo during the observation period
Relationship between adherence and relapse
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
therapeutic intervention group
Interventions/Control_2
observation group
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients were diagnosed as Ulcerative colitis.
2) Mayo Endoscopic score of 1
3) pMayo above 2 and rectal bleeding score of 0
4) Over 16years old and patients to obtain consent for this study.
Key exclusion criteria
Patients with colitis except for Ulcerative colitis.
Patients with gastrointestinal obstruction.
Preoperation patients.
Patients with severe infection.
Patients with malignancy or history of malignancy.
Patients received anti TNF a antibody, tacrolimus or topical therapy.
Inappropriate patients by doctor's judgement.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinano-machi, Shinjyu-ku , Tokyo
TEL
03-3353-1211
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Naganuma |
Organization
Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinano-machi, Shinjyu-ku , Tokyo
TEL
03-3353-1211
Homepage URL
maknaganuma@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Ethics Committee of Keio University
Address
35 Shinano-machi, Shinjyu-ku , Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2018 | Year | 03 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035863
