Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis

Dr. Falk Pharma GmbH1 site in 1 country204 target enrollmentJanuary 15, 2016

InterventionsBudesonide 0.5mg orodispersible tablet twice daily Budesonide 1mg orodispersible tablet twice daily Placebo orodispersible tablet twice daily

DrugsBudesonide 0.5mg orodispersible tablet twice daily Budesonide 1mg orodispersible tablet twice daily Placebo orodispersible tablet twice daily

Overview

Phase: Phase 3
Intervention: Budesonide 0.5mg orodispersible tablet twice daily
Conditions: Eosinophilic Esophagitis
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 204
Locations: 1
Primary Endpoint: Rate of patients free of treatment failure after 48 weeks of treatment.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.

Registry

clinicaltrials.gov

Start Date

January 15, 2016

End Date

December 11, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

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
•Clinico-pathological remission of EoE,
•A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
•Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria

•Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
•History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,
•Patients with PPI-responsive esophageal eosinophilia
•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),
•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,