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Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

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Trial Profile

Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2021

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At a glance

  • Drugs Budesonide (Primary)
  • Indications Eosinophilic oesophagitis
  • Focus Registrational; Therapeutic Use
  • Acronyms EOS-1
  • Sponsors Dr Falk Pharma

Most Recent Events

  • 23 May 2021 Results of a subset analysis assessing the impact of BOT 1mg BID versus placebo for changing the esophageal distensibility during a 6-week induction of remission treatment. presented at the Digestive Disease Week 2021
  • 25 Mar 2019 Results assessing the effectiveness and tolerability of a budesonide orodispersible tablet published in the Gastroenterology.
  • 01 Nov 2017 Primary endpoint has been met. (Rate of clinico-pathological remission) as per results presented at the 25th United European Gastroenterology Week

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