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

Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fuzhenghuayu
Drug: UDCA

First Posted Date: 2016-09-27

Last Posted Date: 2016-09-27

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 200

Registration Number: NCT02916290

Locations: 🇨🇳
Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, China

Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fuzhenghuayu
Drug: UDCA

First Posted Date: 2016-09-27

Last Posted Date: 2016-09-27

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 200

Registration Number: NCT02916641

Locations: 🇨🇳
Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, China

Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment

Phase 1

Completed

Conditions: Rhegmatogenous Retinal Detachment

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2016-07-22

Last Posted Date: 2019-04-25

Lead Sponsor: Francine Behar-Cohen

Target Recruit Count: 26

Registration Number: NCT02841306

Locations: 🇨🇭
University of Lausanne, Lausanne, Switzerland

Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Phase 3

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fenofibrate
Drug: UDCA

First Posted Date: 2016-07-06

Last Posted Date: 2022-09-30

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 104

Registration Number: NCT02823366

Locations: 🇨🇳
Xijing Hosipital, Xi'an, Shaanxi, China

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Phase 3

Completed

Conditions: Primary Biliary Cirrhosis

Interventions: Drug: Fenofibrate
Drug: UDCA

First Posted Date: 2016-07-06

Last Posted Date: 2023-03-08

Lead Sponsor: Xijing Hospital of Digestive Diseases

Target Recruit Count: 117

Registration Number: NCT02823353

Locations: 🇨🇳
Xijing Hosipital, Xi'an, Shaanxi, China

Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

Phase 1

Conditions: Aged

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2016-06-03

Last Posted Date: 2016-06-03

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 16

Registration Number: NCT02789644

Locations: 🇰🇷
Seoul National University Bundang Hospital, Seoul, Korea, Republic of

C. Difficile and Ursodiol

Phase 4

Completed

Conditions: Diarrhea

Interventions: Drug: Ursodiol

First Posted Date: 2016-04-22

Last Posted Date: 2022-01-11

Lead Sponsor: NYU Langone Health

Target Recruit Count: 9

Registration Number: NCT02748616

Locations: 🇺🇸
New York University Langone Medical Center, New York, New York, United States

Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy

Phase 3

Conditions: Cholelithiasis

Interventions: Drug: Placebo
Drug: Ursodeoxycholic Acid
Radiation: Gallbladder Ultrasound

First Posted Date: 2016-03-29

Last Posted Date: 2017-07-14

Lead Sponsor: American University of Beirut Medical Center

Target Recruit Count: 100

Registration Number: NCT02721862

Locations: 🇱🇧
Makassed General Hospital, Beirut, Lebanon
🇱🇧
American University of Beirut Medical Center, Beirut, Lebanon

The Role of Ursodeoxycholic Acid in Treatment of Gallstones in Hemolytic Disorders

Phase 4

Terminated

Conditions: Hemolytic Disorders
Gallstones

Interventions: Drug: Ursodeoxycholic Acid

First Posted Date: 2015-06-16

Last Posted Date: 2017-10-10

Lead Sponsor: Shaare Zedek Medical Center

Target Recruit Count: 3

Registration Number: NCT02472509

Locations: 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel

Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

Phase 2

Withdrawn

Conditions: Cholestasis
Liver Disease

Interventions: Drug: Enteral fish oil
Drug: Ursodeoxycholic Acid
Drug: Placebo

First Posted Date: 2015-04-17

Last Posted Date: 2016-06-21

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Registration Number: NCT02420496

Locations: 🇺🇸
University Hospital, San Antonio, Texas, United States

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