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 trial is active, not recruiting.
|Conditions||cystic fibrosis, gastrointestinal diseases, cholestasis|
|Sponsor||National Center for Research Resources (NCRR)|
|Collaborator||Children's Hospital Medical Center, Cincinnati|
|Start date||November 1995|
|Trial size||20 participants|
|Trial identifier||NCT00004315, 199/11827, UCMC-CHMC-915717|
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.
Male or female participants at least 4 months old.
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
|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.|
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