Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis
| Registry | NCT02434029, acronym EOS-1 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 88 (Actual) |
| Sponsor | Dr. Falk Pharma GmbH (Industry) |
| Conditions | Eosinophilic Esophagitis |
| Interventions | Budesonide 1mg orodispersible tablet twice daily, Placebo orodispersible tablet twice daily (Drug) |
| Dates | start 2015-11-11, primary completion 2016-08-04, completion 2016-10-04, first posted 2015-05-05, last updated 2017-02-03 |
| Locations | 1 site in Germany |
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All trials for Eosinophilic Esophagitis All trials of Budesonide 1mg orodispersible tablet twice daily All trials of Placebo orodispersible tablet twice daily
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Budesonide | Experimental | Drug: Budesonide 1mg orodispersible tablet twice daily | Budesonide 1mg orodispersible tablet twice daily |
| Placebo | Placebo comparator | Drug: Placebo orodispersible tablet twice daily | Placebo orodispersible tablet twice daily |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Center for Digestive Diseases Eppendorf | Hamburg | Germany |
NIH grants: 2014