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A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Alicaforsen (Primary)
  • Indications Pouchitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Atlantic Healthcare; Atlantic Pharmaceuticals

Most Recent Events

  • 27 Oct 2021 Results assessing effect of alicaforsen enema on endoscopic remission and stool frequency presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021
  • 31 Jul 2019 Primary endpoint has not been met. (Proportion of patients with a reduction in relative stool frequency), according to an Atlantic Healthcare media release.
  • 31 Jul 2019 Primary endpoint has not been met. (Proportion of patients with endoscopic remission), according to an Atlantic Healthcare media release.

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