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

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004315

Purpose

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	Intervention	Phase
Cystic Fibrosis Gastrointestinal Diseases Cholestasis	Drug: ursodiol	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Liver Diseases

Drug Information available for: Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	20
Study Start Date:	November 1995

Detailed Description:

PROTOCOL OUTLINE:

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.

Eligibility

Ages Eligible for Study:	4 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004315

Locations

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

Investigators

Study Chair:

William Balistreri

Children's Hospital Medical Center, Cincinnati

More Information

No publications provided

Study ID Numbers:	199/11827, UCMC-CHMC-915717
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004315 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

cardiovascular and respiratory diseases
cholestasis
cystic fibrosis

gastrointestinal disorders
genetic diseases and dysmorphic syndromes
rare disease

Study placed in the following topic categories:

Liver Diseases
Gastrointestinal Diseases
Cholestasis
Fibrosis
Respiration Disorders
Rare Diseases
Ursodeoxycholic Acid
Digestive System Diseases

Genetic Diseases, Inborn
Cystic Fibrosis
Respiratory Tract Diseases
Bile Duct Diseases
Biliary Tract Diseases
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Liver Diseases
Cholestasis
Fibrosis
Gastrointestinal Diseases
Gastrointestinal Agents
Pharmacologic Actions
Ursodeoxycholic Acid
Pathologic Processes
Digestive System Diseases
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Bile Duct Diseases
Therapeutic Uses
Cholagogues and Choleretics
Biliary Tract Diseases
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 02, 2009