Ursodeoxycholic acid

Generic Name: Ursodeoxycholic acid

Brand Names: Reltone, Urso, Urso Forte

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₄₀O_₄

CAS Number: 128-13-2

Unique Ingredient Identifier: 724L30Y2QR

Background: Ursodeoxycholic acid (UDCA), also known as ursodiol, is a naturally-occurring bile acid that constitutes a minor fraction of the human bile acid pool. UDCA has been used to treat liver disease for decades: its first use in traditional medicine dates back more than a hundred years. UDCA was first characterized in the bile of the Chinese black bear and is form...

Indication: Ursodeoxycholic acid is indicated for the treatment of patients with primary biliary cholangitis.

It is used for the short-term treatment of radiolucent, noncalcified gallbladder stones in patients selected for elective cholecystectomy. It is also used to prevent gallstone formation in obese patients experiencing rapid weight loss.

Associated Conditions: Gallstones, Primary Biliary Cholangitis

Associated Therapies: -

Clinical Trials

Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

Not Applicable

Completed

Conditions: Liver Transplantation
Ischemia-reperfusion Injury
Cholestasis

Interventions: Drug: ursodeoxycholic acid
Drug: identical-appearing placebo

First Posted Date: 2010-02-23

Last Posted Date: 2010-12-30

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 112

Registration Number: NCT01073202

Locations: 🇨🇳
Shanghai First People's Hospital, Shanghai, Shanghai, China

Ursodiol Tablets 500 mg Under Fasting Conditions

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Urso Forte™
Drug: Ursodiol

First Posted Date: 2009-05-28

Last Posted Date: 2024-08-19

Lead Sponsor: Teva Pharmaceuticals USA

Target Recruit Count: 80

Registration Number: NCT00909610

Locations: 🇨🇦
Pharma Medica Research Inc., Toronto, Ontario, Canada

Ursodiol 500 mg Tablets Under Fed Conditions

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ursodiol
Drug: Urso Forte™

First Posted Date: 2009-05-28

Last Posted Date: 2024-08-19

Lead Sponsor: Teva Pharmaceuticals USA

Target Recruit Count: 92

Registration Number: NCT00909753

Locations: 🇨🇦
Pharma Medica Research Inc., Toronto, Ontario, Canada

Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

Phase 1

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Biological: bevacizumab
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: ursodiol
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: positron emission tomography (PET)

First Posted Date: 2009-04-01

Last Posted Date: 2024-12-04

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 11

Registration Number: NCT00873275

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Clinical Studies on Bile Acids in Barrett's Esophagus

Not Applicable

Completed

Conditions: Gastroesophageal Reflux Disease

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2009-03-10

Last Posted Date: 2015-04-30

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 60

Registration Number: NCT00858858

Locations: 🇺🇸
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, United States

Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates

Phase 2

Completed

Conditions: Cholestasis

Interventions: Drug: placebo
Drug: Ursodiol

First Posted Date: 2009-02-19

Last Posted Date: 2013-09-17

Lead Sponsor: Ibrahim Mohamed

Target Recruit Count: 26

Registration Number: NCT00846963

Locations: 🇨🇦
CHU Sainte-Justine, Montréal, Quebec, Canada

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Phase 2

Completed

Conditions: Familial Adenomatous Polyposis
Duodenal Neoplasms
Duodenal Polyps

Interventions: Drug: Celecoxib
Drug: Placebo
Drug: Ursodeoxycholic acid

First Posted Date: 2008-12-16

Last Posted Date: 2013-05-16

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 37

Registration Number: NCT00808743

Locations: 🇳🇱
Academic Medical Center, Amsterdam, Netherlands
🇳🇱
University Medical Center, Groningen, Netherlands
🇳🇱
Leiden University Medical Center, Leiden, Netherlands

and more 2 locations

Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)

Phase 3

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Sincalide
Drug: Ursodiol
Procedure: Fat Meal
Procedure: Carb meal
Drug: Placebo

First Posted Date: 2008-06-27

Last Posted Date: 2020-07-22

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Target Recruit Count: 31

Registration Number: NCT00706381

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Pharmacokinetic Investigation of UDCA in Bile and Serum

Phase 1

Completed

Conditions: Healthy

First Posted Date: 2007-09-14

Last Posted Date: 2019-05-07

Lead Sponsor: Dr. Falk Pharma GmbH

Registration Number: NCT00529009

Locations: 🇳🇱
Beuers, Amsterdam, Netherlands

Ursodiol in Huntington's Disease

Phase 1

Conditions: Huntington Disease

Interventions: Drug: ursodiol
Drug: placebo

First Posted Date: 2007-08-10

Last Posted Date: 2009-02-05

Lead Sponsor: Oregon Health and Science University

Target Recruit Count: 21

Registration Number: NCT00514774

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

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