Trials / Terminated
TerminatedNCT03245840
Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 11 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide oral suspension | BOS 10 mL twice daily. |
Timeline
- Start date
- 2017-10-05
- Primary completion
- 2022-04-26
- Completion
- 2022-04-26
- First posted
- 2017-08-10
- Last updated
- 2025-02-19
- Results posted
- 2022-12-07
Locations
45 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03245840. Inclusion in this directory is not an endorsement.