UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023977