98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details
臨床試験数 : 171 / 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141
| 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 | NCT05083312 (ClinicalTrials.gov) | September 30, 2021 | 6/10/2021 | Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial | An 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 Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo oral tablet | Ellodi Pharmaceuticals, LP | NULL | Recruiting | 12 Years | 17 Years | All | 30 | Phase 3 | United States;Australia |
| 2 | EUCTR2019-001521-27-DE (EUCTR) | 03/08/2020 | 10/02/2020 | Study with Eosinophilic Esophagitis subjects | 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 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, LP | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Australia;Germany | ||
| 3 | EUCTR2019-001521-27-ES (EUCTR) | 04/04/2020 | 28/02/2020 | Study with Eosinophilic Esophagitis subjects | 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 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, LP | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Australia;Germany;Switzerland | ||
| 4 | NCT04281108 (ClinicalTrials.gov) | January 30, 2020 | 20/2/2020 | Efficacy 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 Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo oral tablet | Ellodi Pharmaceuticals, LP | NULL | Active, not recruiting | 18 Years | N/A | All | 143 | Phase 3 | Germany;United States;Spain;Australia |
| 5 | EUCTR2016-004749-10-DE (EUCTR) | 15/11/2017 | 26/07/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone 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 Pharmaceutical | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Spain;Belgium;Germany;Switzerland | ||
| 6 | EUCTR2016-004749-10-BE (EUCTR) | 06/10/2017 | 07/07/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone 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 Pharmaceutical | NULL | Not 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): no | United States;Canada;Spain;Belgium;Germany;Switzerland | ||
| 7 | EUCTR2016-004749-10-ES (EUCTR) | 20/09/2017 | 20/09/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone 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 Pharmaceutical | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Belgium;Spain;Germany | ||
| 8 | NCT02778867 (ClinicalTrials.gov) | May 20, 2016 | 12/10/2015 | SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study | Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial | Eosinophilic 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, Cincinnati | National 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) | Completed | 18 Years | 60 Years | All | 129 | Phase 2/Phase 3 | United States |
| 9 | NCT02610816 (ClinicalTrials.gov) | March 21, 2016 | 12/10/2015 | Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids | Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids | Eosinophilic 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, Cincinnati | Patient-Centered Outcomes Research Institute | Completed | 6 Years | 17 Years | All | 67 | Phase 2/Phase 3 | United States |
| 10 | NCT00426283 (ClinicalTrials.gov) | January 2007 | 22/1/2007 | A Study of Flovent in Patients With Eosinophilic Esophagitis | A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Flovent;Other: Placebo | Marc Rothenberg, MD | NULL | Completed | 3 Years | 30 Years | All | 42 | Phase 2 | United States |
| 11 | NCT00266578 (ClinicalTrials.gov) | October 2002 | 15/12/2005 | A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders | Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial | Eosinophilic Esophagitis | Drug: Fluticasone Propionate | Marc Rothenberg | NULL | Completed | 3 Years | 30 Years | Both | 30 | Phase 3 | United States |