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NCT02736409 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Eosinophilic Esophagitis (EoE), sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT02736409 is a Phase 3 study of Eosinophilic Esophagitis (EoE) that has completed, run by Shire. The registered enrollment target is 219 participants, above the 104-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (111% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT02736409, a Phase 3 study of Eosinophilic Esophagitis (EoE), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 104-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (111% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
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.
NCT02736409 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Arizona, Colorado, Connecticut.
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).
What interventions are being tested in trial NCT02736409?
The interventions under investigation include: Placebo (DRUG), Oral Budesonide Suspension (OBS) (DRUG).
Who is sponsoring clinical trial NCT02736409?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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