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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2002 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004315
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2002

October 18, 1999
June 23, 2005
November 1995
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Complete list of historical versions of study NCT00004315 on ClinicalTrials.gov Archive Site
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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
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Gastrointestinal Diseases
  • Cholestasis
Drug: ursodiol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
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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

Both
4 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004315
199/11827, UCMC-CHMC-915717
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National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Study Chair: William Balistreri Children's Hospital Medical Center, Cincinnati
National Center for Research Resources (NCRR)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP