Eosinophilic Esophagitis
Conditions
Brief summary
The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.
Interventions
DRUGlow dose budesonide tablet
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
DRUGhigh dose budesonide tablet
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
DRUGhigh dose budesonide suspension
placebo tablet twice daily AND 5ml \[0.4mg budesonide/ml\] suspension twice daily
DRUGPlacebo
placebo tablet twice daily AND 5ml placebo suspension 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
Major Inclusion Criteria: * Signed informed consent * Male or female patients, 18 to 75 years of age * Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria: (A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf) \- Active symptomatic and histological EoE at baseline Major
Exclusion criteria
* Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia * Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia * Other clinical 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) * Any relevant systemic disease (e.g., AIDS, active tuberculosis) * Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension * Abnormal renal function at screening * History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma) * 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 * Concomitant, or within the 4 weeks prior to screening visit, 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 * Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate * Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment * Intake of grapefruit containing food or beverages during the treatment with study medication * Known intolerance/hypersensitivity to study drug * Existing or intended pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of histological remission | 2 weeks (LOCF) |
| Change in the mean numbers of eos | 2 weeks (LOCF) |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean numbers of eos | 2 weeks (LOCF) |
Countries
Germany
Outcome results
None listed