Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06596252 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Budesonide

Study Locations (20)

California

  • Dr. Falk Investigational Site — La Jolla
  • Dr. Falk Investigational Site — Lomita
  • Dr. Falk Investigational Site — San Diego

Florida

  • Dr. Falk Investigational Site — Doral
  • Dr. Falk Investigational Site — New Port Richey

Louisiana

  • Dr. Falk Investigational Site — Houma
  • Dr. Falk Investigational Site — Marrero

Michigan

  • Wyoming — Ann Arbor
  • Dr. Falk Investigational Site — Wyoming

New Jersey

  • Dr. Falk Investigational Site — Freehold
  • Dr. Falk Investigational Site — Jackson

Ohio

  • Dr. Falk Investigational Site — Cleveland
  • Dr. Falk Investigational Site — Mentor

Arizona

  • Dr. Falk Investigational Site — Scottsdale

Arkansas

  • Dr. Falk Investigational Site — Little Rock

Trial Details

FieldValue
Enrollment Target 308 participants
Start Date 2021-05-21
Est. Completion 2027-03
Phase Phase 3

Sponsor

Dr. Falk Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06596252

The ClinicalTrials.gov registry entry for NCT06596252 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Falk Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 1 intervention — of which Budesonide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06596252 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06596252 about?

NCT06596252 is a clinical study titled "Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE". 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.

What is the current status of trial NCT06596252?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2021-05-21. Estimated completion is 2027-03.

What conditions does trial NCT06596252 study?

This clinical trial studies the following conditions: Eosinophilic Esophagitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06596252?

The interventions under investigation include: Budesonide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06596252?

This trial is sponsored by Dr. Falk Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06596252 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial