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
97	潰瘍性大腸炎	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	NCT02808390 (ClinicalTrials.gov)	November 28, 2016	14/6/2016	Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC	A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis	Ulcerative Colitis	Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo	PPM Services S.A.	NULL	Terminated	18 Years	N/A	All	19	Phase 2	United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine
2	EUCTR2011-003283-78-IT (EUCTR)	09/01/2012	01/03/2012	A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS	A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS	Active Ulcerative Colitis Patients MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: NA Product Code: GED-0507-34-Levo INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid Other descriptive name: NA	GIULIANI	NULL	Not Recruiting			Female: yes Male: yes			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

NCT02808390
(ClinicalTrials.gov)

November 28, 2016

14/6/2016

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo

PPM Services S.A.

NULL

Terminated

18 Years

N/A

All

Phase 2

United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine

EUCTR2011-003283-78-IT
(EUCTR)

09/01/2012

01/03/2012

A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS

Active Ulcerative Colitis Patients
MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: GED-0507-34-Levo
INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid
Other descriptive name: NA

GIULIANI

NULL

Not Recruiting

Female: yes
Male: yes

Italy