UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020774 |
|---|---|
| Receipt number | R000023977 |
| Scientific Title | Clinical study of ursodeoxycholic acid to evaluate the efficacy and safety of ursodeoxycholic acid for the prevention of common bile duct stones following successful removal. |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2022/02/04 11:38:18 |
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Basic information
Public title
Clinical study of ursodeoxycholic acid to evaluate the efficacy and safety of ursodeoxycholic acid for the prevention of common bile duct stones following successful removal.
Acronym
Study of preventive effect of ursodeoxycholic acid on common bile duct stones.
Scientific Title
Clinical study of ursodeoxycholic acid to evaluate the efficacy and safety of ursodeoxycholic acid for the prevention of common bile duct stones following successful removal.
Scientific Title:Acronym
Study of preventive effect of ursodeoxycholic acid on common bile duct stones.
Region
| Japan |
Condition
Condition
Common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive efficacy of ursodeoxycholic acid on the recurrence of common bile duct stones following first successive removal, the patients will be observed for 96 weeks with or without the treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study is the duration until stone recurrence with comparison with untreated groups during 96 weeks of study period.
Key secondary outcomes
The factors regarding stone recurrence will be also investigated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Daily administration of ursodeoxycholic acid for 96 weeks (1-3 divided dose of approximately 10mg/kg body weight)
Interventions/Control_2
no treatment of ursodeoxycholic acid
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
1.Age: 20 years old or older at the time of informed consent.
2.Complete removal of common bile duct stones by endoscopic papillary treatment, and symptom-free period for more than 3 months.
3.No common bile duct stone was proved by CT scan.
Key exclusion criteria
1.A history of gastrectomy.
2.Current treatment for cancer.
3.Complete obstruction of the biliary tract.
4.Current treatment for fulminant hepatitis. Women who were pregnant or breast-feeding, had signs of pregnancy, or were planning to become pregnant.
5.Alcohol abuse.
6.A history of hypersensitivity to the study drug.
7.Current treatment with another bile acid formulation (e.g., Urso or Chino capsule), cholagogue (e.g., dehydrocholic acid, Supacal, Felviten, and Inchinkoto) , bile acid adsorbent (cholestimide or Questran), or agents under development.
8.Patients who were judged to be ineligible for the study by the investigator for other reasons.
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Kanno |
Organization
Hiroshima University Hospital
Division name
Department of General Internal Medicine
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5462
kkanno@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Kanno |
Organization
Hiroshima University Hospital
Division name
Department of General Internal Medicine
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5462
Homepage URL
kkanno@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Biliary Association
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
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, HiroshimaCity, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
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
藤田保健衛生大学坂文種報徳會病院(愛知県)、東邦大学医療センター大森病院（東京都）、名古屋市立大学病院（愛知県）、千葉大学医学部附属病院（千葉県）、埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 31 | 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
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023977
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