Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004315
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
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
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2002-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCMC-CHMC-915717 | None | None | None |