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
51	全身性強皮症	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	EUCTR2016-002984-32-IT (EUCTR)	16/02/2017	05/02/2018	ND	Treatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND	SISTEMIC SCLEROSIS MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST Product Code: ND INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	238	Phase 4	Italy
2	EUCTR2004-002712-28-IT (EUCTR)	28/02/2005	15/02/2006	Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study.	Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study.	Disease progression in scleroderma. MedDRA version: 6.1;Level: HLT;Classification code 10039711	Trade Name: ENDOPROST 0,05MG/0,5ML 1F INN or Proposed INN: iloprost trometamol	ITALFARMACO	NULL	Not Recruiting			Female: yes Male: yes	69	Phase 3	Italy

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

EUCTR2016-002984-32-IT
(EUCTR)

16/02/2017

05/02/2018

Treatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND

SISTEMIC SCLEROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
Product Code: ND
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

238

Phase 4

Italy

EUCTR2004-002712-28-IT
(EUCTR)

28/02/2005

15/02/2006

Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study.

Disease progression in scleroderma.
MedDRA version: 6.1;Level: HLT;Classification code 10039711

Trade Name: ENDOPROST 0,05MG/0,5ML 1F
INN or Proposed INN: iloprost trometamol

ITALFARMACO

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Italy