Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462462
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2007-04-16
Brief Title:
Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96 Formulated in a Gel and Ethanol 98 Solution by the Percutaneous Route in Patients With Congenital Venous MalformationsPharmacokinetic Pharmacodynamic and Clinical Study
Sponsor:
Orfagen
Organization:
Orfagen
Study Overview
Official Title:
Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96 Formulated in a Gel and Ethanol 98 Solution by the Percutaneous Route in Patients With Congenital Venous MalformationsPharmacokinetic Pharmacodynamic and Clinical Study
Status:
COMPLETED
Status Verified Date:
2015-01
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:
Absolute ethanol has been used off-label as an unmodified formulation solution in Congenital Venous Malformations CVM Despite its effectiveness absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation A less diffusible ethanol-based product ethanol gel has been developed in order to minimize systemic and local diffusion capacities of ethanol Therefore the pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel 96 and absolute ethanol need to be carried out
FDA Office of Orphan Products Development FDA OOPD Funding source
FDA Office of Orphan Products Development FDA OOPD Funding source
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