Active eosinophilic esophagitis MedDRA version: 14.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: 1mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent, 2. Male or female patients, 18 to 75 years of age, 3. Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria 4. Active symptomatic and histological EoE 5. Negative pregnancy test in females of childbearing potential at screening visit 2, 6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia, 2. Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia, 3. Other clinical evident causes than EoE for esophageal eosinophilia, 4. Any concomitant esophageal disease and relevant gastro-intestinal disease, 5. Abnormal hepatic function, liver cirrhosis, or portal hypertension, 6. Abnormal renal function, 7. History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma), 8. History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit 2, 9. Upper gastrointestinal bleeding within 8 weeks prior to screening visit 2, 10. Concomitant, or within the 4 weeks prior to screening visit 2, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants, 11. Concomitant, or within the 2 weeks prior to screening visit 2, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate, 12. Installation of dietary restrictions within 4 weeks prior to screening visit 2 or during treatment, 13. Intake of grapefruit containing food or beverages during the treatment with study medication, 14. Known intolerance/hypersensitivity to study drug, 15. History of intolerance/hypersensitivity to propofol, soja or soja oil, saturated triglycerides, lecithin, egg or egg derivatives, if propofol will be used for sedation during endoscopy, 16. Existing or intended pregnancy or breast-feeding,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 2x1 mg/d or 2x2 mg/d budesonide effervescent tablets vs. 2x2 mg/d oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.;Secondary Objective: • To study safety and tolerability in the form of adverse events and laboratory parameters, • To assess patients’ quality of life, • To assess the patient's acceptance and preference of the study drugs. ;Primary end point(s): Primary efficacy endpoint: Rate of histological remission at week 2 (LOCF) Co-primary efficacy endpoint: Change in the mean numbers of eos/mm2 hpf (eosinophil load) from baseline to week 2 (LOCF);Timepoint(s) of evaluation of this end point: week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Rate of histological response at week 2 (LOCF), • Change in the Dysphagia Score, • Adverse events;Timepoint(s) of evaluation of this end point: week 2 | — |
Countries
Belgium, Germany, Switzerland
Contacts
Public ContactProject Management
Aptiv Solutions GmbH
Outcome results
None listed