NCT00462462

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 Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Orfagen · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Venous Malformation

Interventions

Type	Name	Description
DRUG	Ethanol 96% Gel
DRUG	Ethanol 98% Solution

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-04-19
• Last updated: 2015-01-15
• Results posted: 2014-12-12

Locations

2 sites across 2 countries: United States, France