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Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2021-05-21
Completion Date
2027-03
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Budesonide
Twice daily intake of the tablet 30 min after a meal
Locations (26)
Dr. Falk Investigational Site
Scottsdale, Arizona, United States
Dr. Falk Investigational Site
Little Rock, Arkansas, United States
Dr. Falk Investigational Site
La Jolla, California, United States
Dr. Falk Investigational Site
Lomita, California, United States
Dr. Falk Investigational Site
San Diego, California, United States
Dr. Falk Investigational Site
Doral, Florida, United States
Dr. Falk Investigational Site
New Port Richey, Florida, United States
Dr. Falk Investigational Site
Boise, Idaho, United States
Dr. Falk Investigational Site
Houma, Louisiana, United States
Dr. Falk Investigational Site
Marrero, Louisiana, United States
Dr. Falk Investigational Site
Boston, Massachusetts, United States
Wyoming
Ann Arbor, Michigan, United States
Dr. Falk Investigational Site
Wyoming, Michigan, United States
Dr. Falk Investigational Site
Rochester, Minnesota, United States
Dr. Falk Investigational Site
Freehold, New Jersey, United States
Dr. Falk Investigational Site
Jackson, New Jersey, United States
Dr. Falk Investigational Site
New York, New York, United States
Dr. Falk Investigational Site
Chapel Hill, North Carolina, United States
Dr. Falk Investigational Site
Cleveland, Ohio, United States
Dr. Falk Investigational Site
Mentor, Ohio, United States
Wyoming
Philadelphia, Pennsylvania, United States
Dr. Falk Investigational Site
Harlingen, Texas, United States
Dr. Falk Investigational Site
Salt Lake City, Utah, United States
Dr. Falk Investigational Site
Charlottesville, Virginia, United States
Dr. Falk Investigational Site
Lynchburg, Virginia, United States
Department of Gastroenterology, Hospital General de Tomelloso
Tomelloso, Spain