Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis (EOS-1)

Dr. Falk Pharma

Status and phase

Completed

Phase 3

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Placebo orodispersible tablet twice daily

Drug: Budesonide 1mg orodispersible tablet twice daily

Study type

Interventional

Funder types

Industry

Identifiers

NCT02434029

BUL-1/EEA

2014-001484-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.

Enrollment

88 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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,
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,
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,
Existing or intended pregnancy or breast-feeding.