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A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Pancrelipase (Primary)
  • Indications Steatorrhoea
  • Focus Registrational; Therapeutic Use
  • Sponsors Aptalis

Most Recent Events

  • 29 Apr 2016 According to an Allergan media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted a positive opinion for the marketing authorization of pacnrelipase (ENZEPI) for patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
  • 25 Mar 2014 New trial record

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