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NCT00004315 Clinical Trial

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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00004315
Other study ID # 199/11827
Secondary ID UCMC-CHMC-915717
Status Active, not recruiting
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date November 1995

Study information
Verified date April 2002
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Months and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ursodiol

Locations
Country Name City State
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

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