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

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Brief Title

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


Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Cystic Fibrosis

Intervention

ursodiol


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

November 1995



Eligibility Criteria

        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
      

Gender

All

Ages

4 Months - N/A

Accepts Healthy Volunteers

No

Contacts

William Balistreri, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00004315

Organization ID

199/11827

Secondary IDs

UCMC-CHMC-915717


Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 Children's Hospital Medical Center, Cincinnati

Study Sponsor

William Balistreri, Study Chair, Children's Hospital Medical Center, Cincinnati


Verification Date

April 2002