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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00004315 |
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Date of registration:
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18/10/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Date of first enrolment:
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November 1995 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00004315 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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William Balistreri |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Months
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Cholestasis
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Gastrointestinal Diseases
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Intervention(s)
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Drug: ursodiol
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Secondary ID(s)
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UCMC-CHMC-915717
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199/11827
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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