Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004842
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2000-02-24
Brief Title:
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
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 Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid
II Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial
II Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial
Detailed Description:
PROTOCOL OUTLINE
Patients receive budesonide by mouth 3 times daily for a minimum of 6 months If liver biochemistries become normal dosage is reduced to once daily Treatment discontinues after 1 year
Patients receive budesonide by mouth 3 times daily for a minimum of 6 months If liver biochemistries become normal dosage is reduced to once daily Treatment discontinues after 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAYOC-41296 | OTHER | None | None |
| R03DK052344 | NIH | Mayo Clinic | httpsreporternihgovquickSearchR03DK052344 |