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	NCT02736409 (ClinicalTrials.gov)	April 29, 2016	22/3/2016	An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)	A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)	Eosinophilic Esophagitis (EoE)	Drug: Oral Budesonide Suspension (OBS);Drug: Placebo	Shire	NULL	Completed	11 Years	55 Years	All	200	Phase 3	United States;United Kingdom
2	NCT02605837 (ClinicalTrials.gov)	December 7, 2015	4/11/2015	A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved	Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study	Eosinophilic Esophagitis (EoE)	Drug: Oral Budesonide Suspension (OBS);Drug: Placebo	Shire	NULL	Completed	11 Years	55 Years	All	318	Phase 3	United States
3	NCT01642212 (ClinicalTrials.gov)	July 23, 2012	13/7/2012	OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension	Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension	Eosinophilic Esophagitis (EoE)	Drug: Oral Budesonide Suspension (MB-9);Drug: Placebo	Shire	NULL	Completed	11 Years	40 Years	All	93	Phase 2	United States

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

NCT02736409
(ClinicalTrials.gov)

April 29, 2016

22/3/2016

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)

A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis (EoE)

Drug: Oral Budesonide Suspension (OBS);Drug: Placebo

Shire

NULL

Completed

11 Years

55 Years

All

200

Phase 3

United States;United Kingdom

NCT02605837
(ClinicalTrials.gov)

December 7, 2015

4/11/2015

A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study

Eosinophilic Esophagitis (EoE)

Drug: Oral Budesonide Suspension (OBS);Drug: Placebo

Shire

NULL

Completed

11 Years

55 Years

All

318

Phase 3

United States

NCT01642212
(ClinicalTrials.gov)

July 23, 2012

13/7/2012

OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

Eosinophilic Esophagitis (EoE)

Drug: Oral Budesonide Suspension (MB-9);Drug: Placebo

Shire

NULL

Completed

11 Years

40 Years

All

Phase 2

United States