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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

Primary Purpose

Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ursodiol

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cardiovascular and respiratory diseases, cholestasis, cystic fibrosis, gastrointestinal disorders, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

4 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital Medical Center - Cincinnati

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004315

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT00004315

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2002

Overall Recruitment Status

Unknown status

Study Start Date

November 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Children's Hospital Medical Center, Cincinnati

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis

Keywords

cardiovascular and respiratory diseases, cholestasis, cystic fibrosis, gastrointestinal disorders, genetic diseases and dysmorphic syndromes, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ursodiol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Balistreri

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Study Chair

Facility Information:

Facility Name

Children's Hospital Medical Center - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229-3039

Country

United States

12. IPD Sharing Statement

Learn more about this 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

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