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.