NCT00004315

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cystic Fibrosis
• Gastrointestinal Diseases
• Cholestasis

Interventions

Type	Name	Description
DRUG	ursodiol

Timeline

• Start date: 1995-11-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States