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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003732
Receipt No. R000003867
Scientific Title Examination concerning utility of relapse prevention of factor and ursodeoxycholic acid related to relapse after total biliary stone is removed
Date of disclosure of the study information 2010/06/10
Last modified on 2019/07/29

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Basic information
Public title Examination concerning utility of relapse prevention of factor and ursodeoxycholic acid related to relapse after total biliary stone is removed
Acronym Examination concerning utility of relapse prevention of factor and ursodeoxycholic acid related to relapse after total biliary stone is removed
Scientific Title Examination concerning utility of relapse prevention of factor and ursodeoxycholic acid related to relapse after total biliary stone is removed
Scientific Title:Acronym Examination concerning utility of relapse prevention of factor and ursodeoxycholic acid related to relapse after total biliary stone is removed
Region
Japan

Condition
Condition After removing a total biliary stone
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Effectiveness and the safety of the ursodeoxycholic acid in the factor and the relapse control related to the relapse after a total biliary stone is removed are examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient of enforcement of total biliary stone removal art of treatment first time
Comparison research between going side by side groups(Randomizing allocation opening examination)
Research medicine administering group,Passage observation group
Key secondary outcomes It random allocation = allocates it according to the layer.
Example of removing gallbladder, example of having stone having gallbladder, and example of no stone having gallbladder

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Person who takes medicine every day
Interventions/Control_2 Person who doesn't take medicine
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 Patient of enforcement of total biliary stone removal art of treatment first time
1.The age:The age when agreement is acquired is full 20 years old or more.
2.Patient to whom all gallstone in the common bile ducts are removed by passing nipple endoscope treatment
3.Male and Female
4.Patient who obtained agreement of this research participation by document
Key exclusion criteria 1.Patient who has received treatment of gastrectomy
2.Patient who has received treatment by malignant tumor
3.Patient whom biliary tract completely blockaded
4.Patient who has received treatment due to fulminant hepatitis
5.Patient who is scheduling patient and pregnancy with symptom of pregnancy while suckling while getting pregnant
6.Patient of alcoholism
7.Patient who has the past of hypersensitivity for experimental drug
8.Patient who has received treatment with medicine made of bile acid ([uruso]and[chinokapuseru],etc.), bile acid absorbents([korebain]and quest orchis),profit pluck medicines(dehydrocholic acid note, spa curl,[ferubiden],and[inchinkoutou],etc.),and medicines under development
9.Additionally, patient whom research responsibility doctor etc.judged to be suitable case as target in present study









Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tazuma Susumu
Organization Hiroshima University hospital
Division name Department of General Internal Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tazuma Susumu
Organization Hiroshima University hospital
Division name Department of General Internal Medicine
Zip code
Address 1-2-3,Kasumi,Minami-Ku,Hiroshima
TEL 082-257-5461
Homepage URL
Email stazuma@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University hospital
Department of General Internal Medicine
Institute
Department

Funding Source
Organization Hiroshima University hospital
Department of General Internal Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 10 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
2010 Year 03 Month 31 Day
Date of IRB
2010 Year 03 Month 01 Day
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 10 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003867

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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