An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
Public ClinicalTrials.gov record NCT02736409. 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.
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, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.
Study identification
- NCT ID
- NCT02736409
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 219 participants
Conditions and interventions
Conditions
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
- Apr 1, 2016 (Actual)
- Primary completion
- Nov 12, 2019 (Actual)
- Completion
- Nov 12, 2019 (Actual)
- Last update posted
- Feb 19, 2025
2016 – 2019
United States locations
- U.S. sites
- 62
- U.S. states
- 27
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Del Sol Research Management | Tucson | Arizona | 85710 | — |
| Adobe Clinical Research LLC | Tucson | Arizona | 85712 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| GW Research, Inc. | Chula Vista | California | 91910 | — |
| 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 | Lone Tree | Colorado | 80124 | — |
| Connecticut Clinical Research Foundation | Bristol | Connecticut | 06010 | — |
| Connecticut GI, PC - Research Division | Farmington | Connecticut | 06032 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Nature Coast Clinical Research LLC | Inverness | Florida | 34452 | — |
| Arnold Palmer Hospital For Children | Orlando | Florida | 32806 | — |
| Children's Center for Digestive Health Care | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | — | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic | Peoria | Illinois | 61603 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Aquiant Research | New Albany | Indiana | 47150 | — |
| 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 | — |
| Gastroenterology Associates LLC | Baton Rouge | Louisiana | 70809 | — |
| Clinical Trials Management LLC | Metairie | Louisiana | 70006 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71105 | — |
| Clinical Trials of America LA LLC - PPDS | West Monroe | Louisiana | 71291 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | — |
| Minnesota Gastroenterology PA | Plymouth | Minnesota | 55446 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59718 | — |
| Long Island Gastrointestinal Research Group LLP | Great Neck | New York | 11023 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Asheville Gastroenterology Associates PA | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Clinical Trials of America-NC, LLC - PPDS | Mount Airy | North Carolina | 27030 | — |
| Consultants For Clinical Research Inc | Cincinnati | Ohio | 45219 | — |
| 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 | 45415 | — |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Greenville Hospital System | Greenville | South Carolina | 29615 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | — |
| Digestive Health Center | Pasadena | Texas | 77505 | — |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Advanced Research Institute | Sandy City | Utah | 84092 | — |
| Emeritas Research Group | Lansdowne Town Center | Virginia | 20176 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
| Carilion Clinic | Roanoke | Virginia | 24013 | — |
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 NCT02736409, 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 Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02736409 live on ClinicalTrials.gov.