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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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004315     History of Changes
Other Study ID Numbers: 199/11827
UCMC-CHMC-915717
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
cholestasis
cystic fibrosis
gastrointestinal disorders
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Cholestasis
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