Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
Dr. Falk Pharma GmbH
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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…
Interventions
- DrugBudesonide
Twice daily intake of the tablet 30 min after a meal
Locations (26)
- Dr. Falk Investigational SiteScottsdale, Arizona
- Dr. Falk Investigational SiteLittle Rock, Arkansas
- Dr. Falk Investigational SiteLa Jolla, California
- Dr. Falk Investigational SiteLomita, California
- Dr. Falk Investigational SiteSan Diego, California
- Dr. Falk Investigational SiteDoral, Florida