Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03245840 · ClinicalTrials.gov registry record · Phase 3
Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
A Phase 3 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
NCT03245840: Clinical Trial Phase 3 study, sponsored by Shire.
NCT03245840 is a Phase 3 study that was terminated before completion, run by Shire. The registered enrollment target is 133 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03245840, a Phase 3 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in per
Interventions
- DRUG Budesonide oral suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2022-04-26 |
| Phase | Phase 3 |
Why NCT03245840 stopped before completion
NCT03245840 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Budesonide oral suspension is the first listed.
NCT03245840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03245840 about?
NCT03245840 is a clinical study titled "Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)". 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 a...
What is the current status of trial NCT03245840?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2017-10-05. Estimated completion is 2022-04-26.
What interventions are being tested in trial NCT03245840?
The interventions under investigation include: Budesonide oral suspension (DRUG).
Who is sponsoring clinical trial NCT03245840?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03245840's enrollment target sits among peer trials
133 1588th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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
- NCT04276870 · 133 participants · Phase 2
Orphan Indications for CD19 Redirected Autologous T Cells
- NCT04671771 · 133 participants · NA
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
- NCT05610085 · 133 participants · Phase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
- NCT06206486 · 133 participants
The Gut Microbiome and Serum Metabolites As a Biological Mechanism Underlying Pain in Kidney Transplantation
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