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 - Full Text View

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.

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

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis Liver Diseases

Drug Information available for:

Ursodeoxycholic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Study ID Numbers:	199/11827, UCMC-CHMC-915717
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004315
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

Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Cholagogues and Choleretics

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008