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Gastrointestinal |
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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
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Cystic Fibrosis Gastrointestinal Diseases Cholestasis | Drug: ursodiol | Phase II |
MedlinePlus related topics: Bile Duct Diseases; Cystic Fibrosis; Digestive Diseases
Genetics Home Reference related topics: cystic fibrosis
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 20
Study start: November 1995
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.
Eligibility
Ages Eligible for Study: 4 Months and above, Genders Eligible for Study: Both
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
Location Information
Ohio
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, 45229-3039, United States
William Balistreri, Study Chair, Children's Hospital Medical Center - Cincinnati
More Information
Record last reviewed: April 2002
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004315
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Gastrointestinal (HealthWorld)
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