Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204789
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2005-09-12
Brief Title:
Difluoromethylornithine DFMO Chemoprevention of Skin Cancer in Organ Transplant Recipients
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase 2b Difluoromethylornithine DFMO Chemoprevention of Skin Cancer in Organ Transplant Recipients OTR
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double blind placebo controlled study of 52 patients who are at least one-year post-solid organ transplant Subjects will receive either 12 months of DFMO or a placebo The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability will inhibit 12-O-tetradecanoylphorbol-13-acetate TPA-induced ornithine decarboxylase ODC in skin biopsies by approximately 50 for the 12 months of therapy and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CO00318 | None | None | None |