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
Price :
$35
*
At a glance
- Drugs Pancrelipase (Primary)
- Indications Steatorrhoea
- Focus Registrational; Therapeutic Use
- Sponsors Aptalis
- 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