UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003732 |
|---|---|
| Receipt number | 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 13:29:34 |
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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
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
stazuma@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University hospital
Department of General Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003867
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
