COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004315
Recruitment Status : Unknown
Verified April 2002 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:

OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.

II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Gastrointestinal Diseases Cholestasis Drug: ursodiol Phase 2

Detailed Description:


Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Primary Purpose: Treatment
Study Start Date : November 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Ursodiol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

Chronic cholestatic liver disease

Cystic fibrosis-associated liver disease

--Prior/Concurrent Therapy--

Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil

--Patient Characteristics--

Pulmonary: No serious respiratory deficiency

No acute illness

No inability to swallow

No fertile women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004315

Layout table for location information
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Layout table for investigator information
Study Chair: William Balistreri Children's Hospital Medical Center, Cincinnati

Layout table for additonal information Identifier: NCT00004315    
Other Study ID Numbers: 199/11827
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2002
Keywords provided by National Center for Research Resources (NCRR):
cardiovascular and respiratory diseases
cystic fibrosis
gastrointestinal disorders
genetic diseases and dysmorphic syndromes
rare disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents