Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Eosinophilic Esophagitis (EoE), sponsored by Shire.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to t
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 |
What the finished NCT02736409 record still lists
NCT02736409 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (111% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis (EoE)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02736409's enrollment target sits among peer trials
219 2nd of 10 the highest of 10 other Eosinophilic Esophagitis (EoE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis (EoE) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
RECRUITING · Phase 3
-
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
COMPLETED · Phase 3
-
Surface EMG Testing on Swallowing in EoE Patients
RECRUITING
-
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
RECRUITING
-
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
RECRUITING · Phase 4
-
Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05196035 · 219 participants · Phase 3
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
- NCT05608434 · 219 participants · Phase 1
Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial
- NCT05773144 · 219 participants · NA
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
- NCT05907980 · 219 participants · Phase 1
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI