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Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

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Trial Profile

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Therapeutic Use
  • Sponsors Meritage Pharma; Shire

    • Most Recent Events

    • 01 Dec 2023 Results of pooled post hoc analysis (n=76 from studies NCT01642212 and NCT02605837) assessing efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis published in the Journal of Pediatric Gastroenterology and Nutrition
    • 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.
    • 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

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