98. Eosinophilic gastrointestinal disease Clinical trials / Disease details


Clinical trials : 171 Drugs : 184 - (DrugBank : 47) / Drug target genes : 42 - Drug target pathways : 141

  
11 trials found
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1NCT05083312
(ClinicalTrials.gov)
September 30, 20216/10/2021Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 TrialAn Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLRecruiting12 Years17 YearsAll30Phase 3United States;Australia
2EUCTR2019-001521-27-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, LPNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Spain;Australia;Germany
3EUCTR2019-001521-27-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
4NCT04281108
(ClinicalTrials.gov)
January 30, 202020/2/2020Efficacy and Safety APT-1011 in Adult 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 With an Open-label Extension, in Adult Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLActive, not recruiting18 YearsN/AAll143Phase 3Germany;United States;Spain;Australia
5EUCTR2016-004749-10-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
6EUCTR2016-004749-10-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]
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 Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Belgium;Germany;Switzerland
7EUCTR2016-004749-10-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
8NCT02778867
(ClinicalTrials.gov)
May 20, 201612/10/2015SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet StudySix Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid TrialEosinophilic Gastrointestinal Disorders (EGIDs);Eosinophilic Esophagitis (EoE)Other: 1 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet (after 1FED failure);Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Children's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS)Completed18 Years60 YearsAll129Phase 2/Phase 3United States
9NCT02610816
(ClinicalTrials.gov)
March 21, 201612/10/2015Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis;Eosinophilic Gastrointestinal Disorders (EGIDs)Other: 1 Food Elimination Diet;Other: 4 Food Elimination Diet;Other: 4 Food Elimination Diet (post 1FED failure);Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research InstituteCompleted6 Years17 YearsAll67Phase 2/Phase 3United States
10NCT00426283
(ClinicalTrials.gov)
January 200722/1/2007A Study of Flovent in Patients With Eosinophilic EsophagitisA Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Flovent;Other: PlaceboMarc Rothenberg, MDNULLCompleted3 Years30 YearsAll42Phase 2United States
11NCT00266578
(ClinicalTrials.gov)
October 200215/12/2005A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic DisordersEffect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled TrialEosinophilic EsophagitisDrug: Fluticasone PropionateMarc RothenbergNULLCompleted3 Years30 YearsBoth30Phase 3United States