Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

Dr. Falk Pharma GmbH34 sites in 2 countries308 target enrollmentMay 21, 2021

ConditionsEosinophilic Esophagitis

InterventionsBudesonide

DrugsBudesonide

Overview

Phase: Phase 3
Intervention: Budesonide
Conditions: Eosinophilic Esophagitis
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 308
Locations: 34
Primary Endpoint: Proportion of patients in histological remission
Status: Recruiting
Last Updated: 5 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Registry

clinicaltrials.gov

Start Date

May 21, 2021

End Date

March 1, 2027

Last Updated

5 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dr. Falk Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent,
•Male or female patients, 18 to 75 years of age,
•Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
•Active symptomatic and histological EoE
•Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria

•Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
•Achalasia, scleroderma esophagus, or systemic sclerosis,
•Other clinically evident causes than EoE for esophageal eosinophilia,
•Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
•Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
•If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
•Liver cirrhosis or portal hypertension,
•History of cancer in the last five years,
•History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
•Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,