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

Status unconfirmed · Phase 2

Conditions studied: Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis

In brief

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.

Key facts

Study ID

NCT00004315

Run by

National Center for Research Resources (NCRR)

People needed

20

Starts

1995-11-01

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's Hospital Medical Center - Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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