A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI)

Trial Profile

A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI)

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2016

At a glance

  • Drugs Pancrelipase (Primary)
  • Indications Exocrine pancreatic insufficiency; Pancreatitis
  • Focus 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.
    • 24 Dec 2014 New trial record
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