Eosinophilic Esophagitis
Conditions
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.
Interventions
DRUGBudesonide 0.5mg orodispersible tablet twice daily
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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, * 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 baseline visit, * Existing or intended pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients free of treatment failure after 48 weeks of treatment. | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients with histological relapse | 48 weeks |
| Rate of patients with clinical relapse | 48 weeks |
Countries
Germany
Outcome results
None listed