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.

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. - Study of preventive effect of ursodeoxycholic acid on common bile duct stones.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020774

Enrollment

420

Registered

2016-01-31

Start date

2016-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common bile duct stones

Interventions

Daily administration of ursodeoxycholic acid for 96 weeks (1-3 divided dose of approximately 10mg/kg body weight) no treatment of ursodeoxycholic acid

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the duration until stone recurrence with comparison with untreated groups during 96 weeks of study period.	—

Secondary

Measure	Time frame
The factors regarding stone recurrence will be also investigated.	—

Countries

Japan

Contacts

Public ContactKeishi Kanno

Hiroshima University Hospital Department of General Internal Medicine

kkanno@hiroshima-u.ac.jp082-257-5462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026