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P144    (DrugBank: -)

1 disease
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12

51. 全身性強皮症　［臨床試験数：466，薬物数：536（DrugBank：142），標的遺伝子数：110，標的パスウェイ数：210］
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
12 / 466 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2008-001265-28-IT
(EUCTR)		02/03/201007/12/2009Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - NDOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND skin fibrosis of systemic sclerosis patients
MedDRA version: 12.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144. Cytokines Inhibitors
Product Code: P144
INN or Proposed INN: P144 Cytokines Inhibitors		ISDIN S.A.NULLNot RecruitingFemale: yes
Male: yes		98Hungary;United Kingdom;Germany;Spain;Italy
2EUCTR2007-002015-38-IT
(EUCTR)		05/06/200919/06/2009Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - NDPhase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND Skin Fibrosis in patients with systemic sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144ISDIN S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
3EUCTR2008-001265-28-GB
(EUCTR)		14/11/200819/08/2008Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - OLEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - OLE Skin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144. Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream		ISDINNULLNot RecruitingFemale: yes
Male: yes		98Hungary;Germany;United Kingdom;Spain;Italy
4EUCTR2008-001265-28-DE
(EUCTR)		13/10/200819/05/2008OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLEOFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE Skin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144 Cytokine Inhibitor
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream		ISDINNULLNot RecruitingFemale: yes
Male: yes		98Hungary;Spain;Germany;Italy;United Kingdom
5EUCTR2008-001265-28-HU
(EUCTR)		18/09/200805/08/2008Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE Skin fibrosis in patients with systemic sclerosis.Szisztémás szklerózisban szenvedo betegek.
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144 Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream		ISDINNULLNot RecruitingFemale: yes
Male: yes		98Hungary;United Kingdom;Germany;Spain;Italy
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT00781053
(ClinicalTrials.gov)		July 200824/10/2008Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 StudyOpen Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study With P144 Topical Adminsitration for Skin Fibrosis in Patients With Systemic SclerosisSkin FibrosisDrug: P144 creamISDINDigna Biotech S.L.Completed18 Years65 YearsBoth38Phase 2Germany;Hungary;Italy;Poland;Spain;United Kingdom
7EUCTR2008-001265-28-ES
(EUCTR)		17/06/200808/04/2008Estudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLEEstudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE Fibrosis cutánea de pacientes con esclerosis sistémicaSkin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144. Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream		ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		98Hungary;United Kingdom;Germany;Spain;Italy
8EUCTR2007-002015-38-DE
(EUCTR)		20/12/200703/08/2007PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM		ISDINNULLNot RecruitingFemale: yes
Male: yes		98Phase 2Hungary;Spain;Germany;Italy;United Kingdom
9EUCTR2007-002015-38-GB
(EUCTR)		19/12/200731/07/2007 PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma 		ISDINNULLNot Recruiting Female: yes
Male: yes		98Phase 2Hungary;Spain;Germany;Italy;United Kingdom
10EUCTR2007-002015-38-HU
(EUCTR)		04/09/200709/07/2007Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM		ISDINNULLNot RecruitingFemale: yes
Male: yes		98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11NCT00574613
(ClinicalTrials.gov)		September 200713/12/2007Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic SclerosisPhase II, Multicenter, Randomized, Double-blind, Intraindividually Placebo Controlled Clinical Trial, to Evaluate Efficacy and Safety of p144 Topical Administration for Skin Fibrosis in Patients With Systemic SclerosisSkin FibrosisDrug: P144;Drug: placeboISDINDigna Biotech S.L.Completed18 Years65 YearsBoth56Phase 2Germany;Hungary;Italy;Poland;Spain;United Kingdom
12EUCTR2007-002015-38-ES
(EUCTR)		23/08/200702/07/2007ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSISENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM		ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		98Phase 2Hungary;Germany;United Kingdom;Spain;Italy

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