Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis

Dr. Falk Pharma GmbH1 site in 1 country76 target enrollmentJune 2011

ConditionsEosinophilic Esophagitis

Interventionslow dose budesonide tablet high dose budesonide tablet high dose budesonide suspension Placebo

Drugslow dose budesonide tablet high dose budesonide tablet high dose budesonide suspension Placebo

Overview

Phase: Phase 2
Intervention: low dose budesonide tablet
Conditions: Eosinophilic Esophagitis
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 76
Locations: 1
Primary Endpoint: Rate of histological remission
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

May 2014

Last Updated

10 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 clinicopathological diagnosis of EoE according to established diagnostic criteria:
•(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)
•Active symptomatic and histological EoE at baseline

Exclusion Criteria

•Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
•Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
•Other clinical 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)
•Any relevant systemic disease (e.g., AIDS, active tuberculosis)
•Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
•Abnormal renal function at screening
•History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
•History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit
•Upper gastrointestinal bleeding within 8 weeks prior to screening visit