Active eosinophilic esophagitis MedDRA version: 19.0 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concen
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent, - Male or female patients, 18 to 75 years of age, - Confirmed clinico-pathological diagnosis of 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Clinical signs (i.e., acid regurgitation and/or heart burn) and endoscopic signs (at least Los Angeles Classification of Esophagitis Grade A) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).;Secondary Objective: • To study safety and tolerability in the form of adverse events and laboratory parameters, • To assess patients’ quality of life. Exploratory: • To study biomarkers in EoE. ;Primary end point(s): Rate of patients with clinico-pathological remission ;Timepoint(s) of evaluation of this end point: Week 6 (LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of patients with histological remission, - Change from baseline in histology - Rate of patients with resolution of symptoms (i.e., no or only minimal problems of EoE). ;Timepoint(s) of evaluation of this end point: Week 6 (LOCF) | — |
Countries
Belgium, Germany, Netherlands, Spain, Switzerland
Contacts
Public ContactDept. of Clinic. Res. & Development
Dr. Falk Pharma GmbH
Outcome results
None listed