Trial Profile
A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Status:
Discontinued
Phase of Trial:
Phase III
Latest Information Update: 14 Mar 2023
Price :
$35
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At a glance
- Drugs Budesonide (Primary)
- Indications Eosinophilic oesophagitis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Shire
- 08 Mar 2023 Results (n=514) assessing the safety of an investigational formulation of budesonide (budesonide oral suspension; BOS) from six trials (SHP621-101 (no clinical trials registration number), MPI 101-01 (NCT00762073), MPI 101-06 (NCT01642212), SHP621-301 (NCT02605837), SHP621-302 (NCT02736409) and SHP621-303 (NCT03245840)), published in the Alimentary Pharmacology and Therapeutics.
- 16 May 2022 Status changed from active, no longer recruiting to discontinued.
- 27 Oct 2021 Results of a pooled analysis of data from 6 trials (SHP621-101, MPI 101-01, MPI 101-06, SHP621-301, SHP621-302 and SHP621-303) assessing the long term safety of Budesonide oral suspension presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021