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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028574
Receipt No. 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 2018/07/18

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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
Email 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
Email ymatsuno@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 15 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
2017 Year 08 Month 08 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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