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Apt-1011    (DrugBank: -)

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
98好酸球性消化管疾患7

98. 好酸球性消化管疾患　［臨床試験数：128，薬物数：147（DrugBank：40），標的遺伝子数：34，標的パスウェイ数：132］
Searched query = "Eosinophilic gastrointestinal disease", "Eosinophilic gastroenteritis", "Eosinophilic esophagitis", "Eosinophilic colitis", "Eosinophilic gastro-intestinal disorder", "EGID", "Neonatal food-protein induced enterocolitis", "N-FPIES"
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.
7 / 128 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2019-001521-27-DE
(EUCTR)		03/08/202010/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE		Adare Pharmaceuticals US, LPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		120Phase 3United States;Spain;Australia;Germany
2EUCTR2019-001521-27-ES
(EUCTR)		04/04/202028/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE		Adare Pharmaceuticals US, LPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		120Phase 3United States;Spain;Australia;Germany;Switzerland
3NCT04281108
(ClinicalTrials.gov)		January 30, 202020/2/2020Efficacy and Safety APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletAdare Pharmaceuticals, Inc.NULLRecruiting15 YearsN/AAll120Phase 3United States
4EUCTR2016-004749-10-DE
(EUCTR)		15/11/201726/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: APT-1011
INN or Proposed INN: FLUTICASONE PROPIONATE
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE		Adare PharmaceuticalNULLNot RecruitingFemale: yes
Male: yes		100Phase 2United States;Canada;Spain;Belgium;Germany;Switzerland
5EUCTR2016-004749-10-BE
(EUCTR)		06/10/201707/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Adare PharmaceuticalNULLNot Recruiting Female: yes
Male: yes		100Phase 2United States;Canada;Spain;Belgium;Germany;Switzerland
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2016-004749-10-ES
(EUCTR)		20/09/201720/09/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE		Adare PharmaceuticalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		100Phase 2United States;Canada;Belgium;Spain;Germany
7NCT03191864
(ClinicalTrials.gov)		June 30, 201715/6/2017Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: PlaceboAdare Pharmaceuticals, Inc.NULLActive, not recruiting18 Years75 YearsAll106Phase 2United States;Belgium;Canada;Germany;Spain;Switzerland

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