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Active, not recruiting Phase 3

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

NCT06596252 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2021-05-21
Last updated
2026-08-28

Condition(s) studied

Eosinophilic Esophagitis

Investigational drug(s) / intervention(s)

Budesonide →

Budesonide: Twice daily intake of the tablet 30 min after a meal

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
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 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, hepatitis B or C), * 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 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture * Upper gastrointestinal bleeding within 8 weeks prior to baseline visit, * Existing or intended pregnancy or breast-feeding.

Primary outcome measure(s)

  • Proportion of patients in histological remission — 6 weeks
    Histological assessment of biopsies taken at end of treatment visit

Trial sites (21)

FacilityCityRegionStatus
Dr. Falk Investigational Site Scottsdale Arizona
Dr. Falk Investigational Site Little Rock Arkansas
Dr. Falk Investigational Site La Jolla California
Dr. Falk Investigational Site San Diego California
Dr. Falk Investigational Site Doral Florida
Dr. Falk Investigational Site New Port Richey Florida
Dr. Falk Investigational Site Boise Idaho
Dr. Falk Investigational Site Boston Massachusetts
Wyoming Ann Arbor Michigan
Dr. Falk Investigational Site Wyoming Michigan
Dr. Falk Investigational Site Rochester Minnesota
Dr. Falk Investigational Site Freehold New Jersey
Dr. Falk Investigational Site New York New York
Dr. Falk Investigational Site Chapel Hill North Carolina
Dr. Falk Investigational Site Cleveland Ohio
Dr. Falk Investigational Site Mentor Ohio
Wyoming Philadelphia Pennsylvania
Dr. Falk Investigational Site Harlingen Texas
Dr. Falk Investigational Site Salt Lake City Utah
Dr. Falk Investigational Site Lynchburg Virginia
Department of Gastroenterology, Hospital General de Tomelloso Tomelloso Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06596252 on ClinicalTrials.gov ↗ ← All trials in Spain