DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
279	巨大静脈奇形（頚部口腔咽頭びまん性病変）	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2009-011276-29-FR (EUCTR)	21/08/2009	15/05/2009	Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.	Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.	patients with congenital venous malformations (CVM)	Product Name: Ethanol gel Product Code: L0122 Other descriptive name: ETHANOL (96 PER CENT) Trade Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection Product Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection Other descriptive name: ETHANOL BP	ORFAGEN	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24		France
2	NCT00462462 (ClinicalTrials.gov)	May 2007	16/4/2007	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.	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.	Congenital Venous Malformation	Drug: Ethanol 96% Gel;Drug: Ethanol 98% Solution	Orfagen	FDA Office of Orphan Products Development	Completed	12 Years	N/A	All	32	Phase 2	United States;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-011276-29-FR
(EUCTR)

21/08/2009

15/05/2009

Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.

patients with congenital venous malformations (CVM)

Product Name: Ethanol gel
Product Code: L0122
Other descriptive name: ETHANOL (96 PER CENT)
Trade Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Product Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Other descriptive name: ETHANOL BP

ORFAGEN

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

NCT00462462
(ClinicalTrials.gov)

May 2007

16/4/2007

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.

Congenital Venous Malformation

Drug: Ethanol 96% Gel;Drug: Ethanol 98% Solution

Orfagen

FDA Office of Orphan Products Development

Completed

12 Years

N/A

All

Phase 2

United States;France