Trial Profile
Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 21 Jun 2019
Price :
$35
*
At a glance
- Drugs Pancrelipase (Primary) ; Pancreatin
- Indications Exocrine pancreatic insufficiency; Pancreatic disorders
- Focus Therapeutic Use
- Sponsors Adare Pharmaceuticals
- 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.
- 29 Apr 2015 New trial record