RecruitingPhase 3NCT06596252

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

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

Sponsor

Dr. Falk Pharma GmbH

Enrollment

308 participants

Start Date

May 21, 2021

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two dosing schedules of budesonide orodispersible tablets — a dissolvable steroid tablet taken by mouth — for treating active eosinophilic esophagitis (EoE), a chronic inflammatory condition of the esophagus caused by an immune reaction. Researchers want to find out whether taking 1 mg twice daily for 6 weeks works as well as taking 2 mg once daily at inducing remission. Eligible participants are adults aged 18–75 with a confirmed diagnosis of active EoE and no competing conditions like gastroesophageal reflux disease, active infection, or pregnancy. Participation involves taking the assigned tablet regimen for 6 weeks and undergoing clinical assessments including endoscopy to check whether the condition has gone into remission. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBudesonide

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

View Full Details on ClinicalTrials.gov

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NCT06596252