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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)
NCT02736409 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oral Budesonide Suspension (OBS)
Study Locations (20)
Arizona
- Phoenix Childrens Hospital — Phoenix
- Del Sol Research Management — Tucson
- Adobe Clinical Research LLC — Tucson
Colorado
- Colorado Children's Hospital — Aurora
- Asthma and Allergy Associates PC — Colorado Springs
- Rocky Mountain Pediatric Gastroenterology — Lone Tree
Connecticut
- Connecticut Clinical Research Foundation — Bristol
- Connecticut GI, PC - Research Division — Farmington
- Connecticut Children's Medical Center — Hartford
California
- GW Research, Inc. — Chula Vista
- Rady Children's Hospital San Diego — San Diego
Florida
- Nature Coast Clinical Research LLC — Inverness
- Arnold Palmer Hospital For Children — Orlando
Georgia
- Children's Center for Digestive Health Care — Atlanta
- Gastroenterology Associates of Central Georgia, LLC — Macon
Illinois
- Northwestern University — Chicago
- University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic — Peoria
Alabama
- Children's Hospital — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2019-11-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02736409
The ClinicalTrials.gov registry entry for NCT02736409 describes a study currently listed as completed. 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 219 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 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 (EoE) appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02736409 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Arizona, Colorado, Connecticut. 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 NCT02736409 about?
NCT02736409 is a clinical study titled "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)". 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 eval...
What is the current status of trial NCT02736409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2016-04-01. Estimated completion is 2019-11-12.
What conditions does trial NCT02736409 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis (EoE). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02736409?
The interventions under investigation include: Placebo (DRUG), Oral Budesonide Suspension (OBS) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02736409?
This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02736409 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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