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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2002 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004315
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2002
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Ursodiol
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

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

Additional relevant MeSH terms:
Cholestasis
Cystic Fibrosis
Fibrosis
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pancreatic Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013