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

ClinicalTrials.gov ID: NCT06596252

Public ClinicalTrials.gov record NCT06596252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 6:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06596252
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Dr. Falk Pharma GmbH; Industry
Enrollment: 308 participants

Conditions and interventions

Conditions

Eosinophilic Esophagitis

Interventions

Budesonide Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2021 (Actual)
Primary completion: Dec 2026 (Estimated)
Completion: Mar 2028 (Estimated)
Last update posted: Aug 28, 2026

2021 – 2028

United States locations

U.S. sites: 20
U.S. states: 16
U.S. cities: 20

Facility	City	State	ZIP	Site status
Dr. Falk Investigational Site	Scottsdale	Arizona	85259	—
Dr. Falk Investigational Site	Little Rock	Arkansas	72205	—
Dr. Falk Investigational Site	La Jolla	California	92037	—
Dr. Falk Investigational Site	San Diego	California	92193	—
Dr. Falk Investigational Site	Doral	Florida	83706	—
Dr. Falk Investigational Site	New Port Richey	Florida	34653	—
Dr. Falk Investigational Site	Boise	Idaho	83706	—
Dr. Falk Investigational Site	Boston	Massachusetts	02111	—
Wyoming	Ann Arbor	Michigan	48109	—
Dr. Falk Investigational Site	Wyoming	Michigan	49519	—
Dr. Falk Investigational Site	Rochester	Minnesota	55905	—
Dr. Falk Investigational Site	Freehold	New Jersey	07728	—
Dr. Falk Investigational Site	New York	New York	10075	—
Dr. Falk Investigational Site	Chapel Hill	North Carolina	27599-7080	—
Dr. Falk Investigational Site	Cleveland	Ohio	44195	—
Dr. Falk Investigational Site	Mentor	Ohio	44060	—
Wyoming	Philadelphia	Pennsylvania	19104	—
Dr. Falk Investigational Site	Harlingen	Texas	78550	—
Dr. Falk Investigational Site	Salt Lake City	Utah	85259	—
Dr. Falk Investigational Site	Lynchburg	Virginia	24502	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06596252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 28, 2026 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06596252 live on ClinicalTrials.gov.

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