Eosinophilic Esophagitis
Conditions
Brief summary
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
Interventions
DRUGBudesonide
Twice daily intake of the tablet 30 min after a meal
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, controlled interventional study phase followed by an optional open-label extension phase
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 * Active symptomatic and histological EoE * Negative pregnancy test in females of childbearing potential at baseline visit.
Exclusion criteria
* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD), * 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, hepatitis B or C), * 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 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture * Upper gastrointestinal bleeding within 8 weeks prior to baseline visit, * Existing or intended pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in histological remission | 6 weeks | Histological assessment of biopsies taken at end of treatment visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in clinical remission | 6 weeks | Assessment of clinical scores assessed with questionnaires at the end of treatment visit |
Countries
Spain, United States
Contacts
STUDY_DIRECTORAlfredo J Lucendo, MD, PhD
Department of Gastroenterology, Hospital General de Tomelloso, Spain
Outcome results
None listed