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Terminated Phase 3 Interventional Results available

Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)

ClinicalTrials.gov ID: NCT03245840

Public ClinicalTrials.gov record NCT03245840. 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.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 8:28 PM EDT

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

Official title

A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)

Brief summary

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

This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302 extension study. The purpose of this study is to see if BOS is safe and well tolerated over the long-term in adolescents and adults with EoE.

Study identification

NCT ID
NCT03245840
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
133 participants

Conditions and interventions

Eligibility (public fields only)

Age range
11 Years to 55 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
Oct 5, 2017 (Actual)
Primary completion
Apr 26, 2022 (Actual)
Completion
Apr 26, 2022 (Actual)
Last update posted
Feb 19, 2025

2017 – 2022

United States locations

U.S. sites
45
U.S. states
26
U.S. cities
42
Facility City State ZIP Site status
Children's Hospital Birmingham Alabama 35233 —
Phoenix Childrens Hospital Phoenix Arizona 85016 —
Del Sol Research Management Tucson Arizona 85712 —
Arkansas Gastroenterology North Little Rock Arkansas 72117 —
Rady Children's Hospital San Diego San Diego California 92123 —
Colorado Children's Hospital Aurora Colorado 80045 —
Asthma and Allergy Associates PC Colorado Springs Colorado 80907 —
Rocky Mountain Pediatric Gastroenterology Denver Colorado 80218 —
Connecticut Clinical Research Foundation Bristol Connecticut 06010 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Connecticut GI Hartford Connecticut 06106 —
Nature Coast Clinical Research LLC Inverness Florida 34452 —
Arnold Palmer Hospital for Children Orlando Florida 32806 —
Childrens Center For Digestive Healthcare Atlanta Georgia 30342 —
Gastroenterology Associates of Central Georgia Macon Georgia 31201 —
Grand Teton Research Group Idaho Falls Idaho 83404 —
Northwestern University Chicago Illinois 60611 —
Gastroenterology of Southern Indiana New Albany Indiana 47150 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Cotton O'Neil Clinical Research Center Topeka Kansas 66606 —
Indiana University Louisville Kentucky 40202 —
Gastroenterology Associates, LLC Baton Rouge Louisiana 70809 —
Clinical Trials Management LLC Metairie Louisiana 70006 —
Tufts Medical Center Boston Massachusetts 00211 —
Boston Children's Hospital Boston Massachusetts 02115 —
Brigham and Womens Hospital Chestnut Hill Massachusetts 02467 —
Minnesota Gastroenterology PA Plymouth Minnesota 55446 —
Mount Sinai Hospital, Icahn School of Medicine Astoria New York 11102 —
Long Island Gastrointestinal Research Group LLP Great Neck New York 11023 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 —
Clinical Research of Charlotte Charlotte North Carolina 28277 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
University of Cincinnati Cincinnati Ohio 45267 —
Cleveland Clinic Cleveland Ohio 44195 —
Gastrointestinal and Liver Diseases Consultants PC Dayton Ohio 45440 —
Great Lakes Gastroenterology Mentor Ohio 44060 —
Digestive Disease Specialists, Inc. Oklahoma City Oklahoma 73112 —
Greenville Hospital Greenville South Carolina 29615 —
Gastro One Germantown Tennessee 38138 —
Vanderbilt University Medical Center Nashville Tennessee 37212 —
Houston Endoscopy and Research Center Houston Texas 77024 —
Advanced Research Institute Ogden Utah 84405 —
Primary Children's Hospital, University of Utah Salt Lake City Utah 84132 —
Emeritas Research Group Lansdowne Town Center Virginia 20176 —
Blue Ridge Medical Research 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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03245840, 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 Feb 19, 2025 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03245840 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →