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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.

NCT00462462 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-01-15

Study results available
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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

DRUG

Ethanol 96% Gel

DRUG

Ethanol 98% Solution

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Orfagen

    lead INDUSTRY

Principal Investigators

  • PATRICK DUPUY, MD · ORFAGEN LABORATORIES (France)

  • SALLY E MITCHELL, MD · Johns Hopkins Medical Institution (Baltimore, USA)

  • Denis HERBRETEAU, MD · Hôpital Bretonneau (Tours, France)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00462462 on ClinicalTrials.gov