UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028574 |
|---|---|
| Receipt number | R000032212 |
| Scientific Title | Further maintenance of remission for a year after Qing-Dai withdrawalin ulcerative colitis treatment:randomized controlled trial |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2022/08/12 22:12:04 |
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Basic information
Public title
Further maintenance of remission for a year after Qing-Dai withdrawalin ulcerative colitis treatment:randomized controlled trial
Acronym
Further maintenance of remission for a year after Qing-Dai withdrawalin ulcerative colitis treatment:randomized controlled trial
Scientific Title
Further maintenance of remission for a year after Qing-Dai withdrawalin ulcerative colitis treatment:randomized controlled trial
Scientific Title:Acronym
Further maintenance of remission for a year after Qing-Dai withdrawalin ulcerative colitis treatment:randomized controlled trial
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the feasibility of stopping Qing-Dai and the profile of the patients who could stop
Qing-Dai by comparing the remission rate between patients who stop and continue Qing-Dai after 52 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
remission rate after 52 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
stop oral administration of Qing-Dai
Interventions/Control_2
continue oral administration of Qing-Dai
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 who undergo the treatment of Qing-Dai over a year
2) Patients whose disease activity is 1 or 0 by Mayo endoscopic score
3) Patients who received full-explanation and completely understood the study.
4) Patients with no change in treatment within the past 2 weeks before the commencement of the study
5) Patients with no change in treatment of ulcerative colitis during their oral administration of Qing-Dai
6) Patients who have voluntarily submitted written consent forms upon participation in this study
Key exclusion criteria
1)Pregnant or breastfeeding women
2)Patients who have a history of psychosomatic disorders
3)Patients who have a history of liver or renal diseases
4)Patients who have a history of antithrombotic therapy or thrombocytopenia
5)Patients who have a history of hepatitis B
6)Patients whom investigators and subinvestigators considered inappropriate to participate in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanari Kitazono |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1,Higashi-ku,Fukuoka
TEL
092-642-5261
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Matsuno |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1,Higashi-ku,Fukuoka
TEL
092-642-5261
Homepage URL
ymatsuno@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu 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
九州大学病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 15 | 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
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032212
