UMIN-CTR Clinical Trial

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