Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158041
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-07
Brief Title:
Subcutaneous Amifostine Safety Study
Sponsor:
Mt Sinai Medical Center Miami
Organization:
Mt Sinai Medical Center Miami
Study Overview
Official Title:
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol Amifostine for the Prevention of Radiation-Induced Toxicities
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route The study evaluated the safety of amifostine administered subcutaneously The four targeted toxicities were nauseavomiting hypotension generalized skin rash and injection-site skin reactions
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