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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00004315 |
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 | Intervention | Phase |
|
Cystic Fibrosis Gastrointestinal Diseases Cholestasis |
Drug: ursodiol |
Phase II |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis Liver Diseases |
| Drug Information available for: | Ursodeoxycholic acid |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 20 |
| Study Start Date: | 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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |||||
| Children's Hospital Medical Center - Cincinnati | |||||
| Cincinnati, Ohio, United States, 45229-3039 | |||||
| National Center for Research Resources (NCRR) |
| Children's Hospital Medical Center, Cincinnati |
| Study Chair: | William Balistreri | Children's Hospital Medical Center, Cincinnati |
More Information
| Study ID Numbers: | 199/11827, UCMC-CHMC-915717 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004315 |
| Health Authority: | United States: Federal Government |
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