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	EUCTR2017-003737-29-NL (EUCTR)	01/04/2020	09/04/2019	Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis	Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis	Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 2;Phase 3	Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom
2	EUCTR2017-003737-29-PT (EUCTR)	24/05/2019	29/01/2019	Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis	Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis	Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	75	Phase 2;Phase 3	Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom

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

EUCTR2017-003737-29-NL
(EUCTR)

01/04/2020

09/04/2019

Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis

Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis

Active eosinophilic esophagitis and maintenance of remission in 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: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2;Phase 3

Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom

EUCTR2017-003737-29-PT
(EUCTR)

24/05/2019