Overview

Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Status:
Completed
Trial end date:
2016-10-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr. Falk Pharma GmbH
Treatments:
Budesonide
Criteria
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,

- 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.

Exclusion Criteria:

- Clinical and endoscopic signs 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.