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
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Gastrointestinal Diseases; Cholestasis
Intervention: ursodiol (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
William Balistreri, Study Chair, Affiliation: Children's Hospital Medical Center, Cincinnati
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.
Clinical Details
Study design: Treatment
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
Minimum age: 4 Months.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States
Additional Information
Starting date: November 1995
Last updated: June 23, 2005
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