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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020774
Receipt No. 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 2021/02/02

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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
Email 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
Email kkanno@hiroshima-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Hiroshima University Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2021 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
2021 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023977

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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