DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 0.5 mg budesonide effervescent tablet for orodispersible use; 1 mg budesonide effervescent tablet for orodispersible use; 1mg budesonide effervescent tablet for orodispersible use; 2mg budesonide effervescent tablet for orodispersible use; 5 mg Montelukast; AK002; APT-1011; APT-1011 - 3 mg; Allergen; Allergy immunotherapy (allergy shots); Antolimab; BUDESONIDE; BUET 0.5 mg; BUET 1mg; BUET 2mg; BUU 0.4mg/ml; Barium; Beclomethasone dipropionate; Behavioral: six-foods elimination diet; Benralizumab; Bethanechol; Budesonide; Budesonide 0.5mg orodispersible tablet twice daily; Budesonide 1mg orodispersible tablet twice daily; Budesonide [0.4mg/ml] viscous suspension; Budesonide oral suspension; Budesonide oral suspension [0.2 mg/ml]; Budesonide plus Prevacid; CALY-002; Cromolyn; DUPILUMAB; Device: EsophaCap; Device: Intraluminal Impedance; Device: NIOX MINO® Airway Inflammation Monitor; Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy; Dexlansoprazole; Diagnostic Test: Barium Esophagram; Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Endoscopy while on study drug; Diagnostic Test: Height measurement; Diagnostic Test: Physical Examination and Questionnaires; Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug; Diagnostic Test: Vitamin D Measurement; Dupilumab; Dupilumab (blinded); Dupilumab (open-label); Dupixent; ESO-101; EUR-1100; Esomeprazole; FLUTICASONE PROPIONATE; Famotidine; Florence 30 µg/mL; Florence 60 µg/mL; Florence 90 µg/mL; Flovent; Fluticasone; Fluticasone MDI; Fluticasone Propionate; Fluticasone Propionate, 800 mcg twice daily (post 4FED failure); Fluticasone Propionate, 880 mcg twice daily (after 6FED failure); Fluticasone Propionate, USP; Fluticasone propionate; Gold; High dose budesonide suspension; High dose budesonide tablet; Honey; Infliximab; Inhaled/swallowed budesonide; Intubated with Propofol (IP); Intubated with Sevoflurane (IS); Lansoprazole; Lirentelimab; Lirentelimab (AK002); Loratadine; Losartan; Losartan Potassium; Low dose budesonide tablet; MEDI-563; MOMETASONE FUROATE; MONITOR; Mepolizumab; Mepolizumab 100 mg; Mepolizumab 300 mg; Milk; Mometasone; Mometasone furoate; Montelukast; Montelukast/ Singulair; Nasonex; Nitric Oxide; OC000459; Omalizumab; Omeprazole; Omeprazole 20mg BID; Oral Budesonide; Oral Budesonide Suspension (MB-9); Oral Budesonide Suspension (OBS); Oral Viscous Budesonide; Oral Viscous Budesonide (OVB); Oral cromolyn sodium; Other: 1 Food Elimination Diet; Other: 1 Food Elimination Diet Therapy; Other: 4 Food Elimination Diet; Other: 4 Food Elimination Diet (post 1FED failure); Other: 6 Food Elimination Diet (after 1FED failure); Other: 6 Food Elimination Diet Therapy; Other: Antigen (wheat base soy sauce) spray; Other: Assessment of medication compliance; Other: D-xylose; Other: Elimination diet; Other: Honey; Other: Medication Compliance Phone Call; Other: Oral Nitric Oxide testing; Other: Saline; Other: Symptom Survey; Other: Xanthan Gum; Potassium; Procedure: Esophageal dilation; Procedure: Esophagogastroduodenoscopy; Procedure: Intraluminal Impedance; Propofol; QAX576; RPC4046; Radiation: Computerized Tomography scan; Radiation: Esophageal Barium Xray; Radiation: Planar Images; Radiation: Single Photon Emission Computed Tomography scans; Reslizumab; SB-240563; SCH55700; Sevoflurane; Sirolimus; Steroid and Proton Pump Inhibitor Therapy; Sucralfate; Swallowed fluticasone; Technetium Tc 99M; Technetium Tc 99m; Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms; Viaskin Milk 500 mcg; Viscous/swallowed budesonide; Vitamin D; Vonoprazan; Wheat; Xanthan gum; Xylose; Zofran - no intubation

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	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

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

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

EUCTR2019-001521-27-ES
(EUCTR)

04/04/2020

28/02/2020

Study with Eosinophilic Esophagitis subjects

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

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

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.

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

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

EUCTR2016-004749-10-ES
(EUCTR)

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

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