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
Recruitment status was: Active, not recruiting
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.
|Cystic Fibrosis Gastrointestinal Diseases Cholestasis||Drug: ursodiol||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||November 1995|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004315
|United States, Ohio|
|Children's Hospital Medical Center - Cincinnati|
|Cincinnati, Ohio, United States, 45229-3039|
|Study Chair:||William Balistreri||Children's Hospital Medical Center, Cincinnati|