GED0507 ( DrugBank: - )


1 disease
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6

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001684-36-ES
(EUCTR)
19/04/201710/03/2017EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA 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
MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO
PPM SERVICES SANULLNot RecruitingFemale: yes
Male: yes
207Phase 2France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy
2EUCTR2016-001684-36-LV
(EUCTR)
20/02/201722/12/2016EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA 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
MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO
PPM SERVICES SANULLNot RecruitingFemale: yes
Male: yes
207Phase 2France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy
3EUCTR2016-001684-36-SK
(EUCTR)
12/12/201626/07/2016EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA 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
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO
PPM SERVICES SANULLNot RecruitingFemale: yes
Male: yes
207Phase 2France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom
4NCT02808390
(ClinicalTrials.gov)
November 28, 201614/6/2016Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UCA 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 ColitisUlcerative ColitisDrug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: PlaceboPPM Services S.A.NULLTerminated18 YearsN/AAll19Phase 2United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine
5EUCTR2016-001684-36-BG
(EUCTR)
17/11/201618/10/2016EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA 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
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 100000016704
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO
PPM SERVICES SANULLNot RecruitingFemale: yes
Male: yes
207Phase 2France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom
6EUCTR2016-001684-36-HU
(EUCTR)
19/10/201610/08/2016EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITISA 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
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO
PPM SERVICES SANULLNot RecruitingFemale: yes
Male: yes
207Phase 2United States;Slovakia;Spain;Ukraine;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Bulgaria;Latvia