eosinophilic esophagitis MedDRA version: 20.1 Level: PT Classification code 10064212 Term: Eosinophilic oesophagitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg)
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Co
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent, - Man or woman 18 to 75 years of age, - Confirmed diagnosis of eosinophilic esophagitis (EoE) - Active symptomatic and histological EoE - At least 4 points in Patient’s Global Assessment (PatGA) concerning the severity of EoE symptoms 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 196 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: - gastroesophageal reflux disease (GERD), - Achalasia, scleroderma esophagus, or systemic sclerosis, - clinically evident causes for esophageal eosinophilia other than EoE - Any concomitant esophageal disease and relevant active gastro-intestinal disease - abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease - History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture - Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline, - Treatment with medication, that could compromise/influence the effects of the study treatment, assessment of the endpoints and/or patients' safety, during or within too narrow timeframe of the clinical trial (e.g. immunosuppressants, CYP3A4 inhibitors, live vaccination, non-stable treatment with proton pump inhibitors) - exiting or intended pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the non-inferiority of 1 x 2 mg/d vs. 2 x 1 mg/d budesonide orodispersible tablets for the induction of histological remission in adult patients with active eosinophilic esophagitis (EoE);Secondary Objective: - To further assess EoE-associated clinical, endoscopic, and histological findings after 6 weeks treatment with budesonide orodispersible tablets, - To study safety and tolerability as assessed by adverse events and laboratory parameters, - To assess patients’ quality of life;Primary end point(s): Proportion of patients with histological remission ;Timepoint(s) of evaluation of this end point: week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF), 2. Change in the severity of dysphagia 3. Change in the severity of odynophagia 4. Change of overall severity of EoE symptoms 5. Change in the total weekly Eosinophilic Esophagitis Activity Index;Timepoint(s) of evaluation of this end point: week 6 (for secondary endpoints 1 - 5) | — |
Countries
Austria, Canada, Germany, Portugal, Russian Federation, Spain, Switzerland
Contacts
Public ContactDept. of Clinical R&D
Dr. Falk Pharma GmbH
Outcome results
None listed