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

NCT06596252 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2026-04-27

No results posted yet for this 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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

Budesonide

Twice daily intake of the tablet 30 min after a meal

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Alfredo J Lucendo, MD, PhD · Department of Gastroenterology, Hospital General de Tomelloso, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596252 on ClinicalTrials.gov