Apt-1011 (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
---|---|---|
98 | Eosinophilic gastrointestinal disease | 7 |
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 |
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1 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Australia;Germany | ||
2 | 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 | ||
3 | NCT04281108 (ClinicalTrials.gov) | January 30, 2020 | 20/2/2020 | Efficacy 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 Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo oral tablet | Adare Pharmaceuticals, Inc. | NULL | Recruiting | 15 Years | N/A | All | 120 | Phase 3 | United States |
4 | 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 | ||
5 | 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] | Adare Pharmaceutical | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Spain;Belgium;Germany;Switzerland | |||
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 |
6 | 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 | ||
7 | NCT03191864 (ClinicalTrials.gov) | June 30, 2017 | 15/6/2017 | Efficacy, 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 Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo | Adare Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 106 | Phase 2 | United States;Belgium;Canada;Germany;Spain;Switzerland |