A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
Phase of Trial: Phase II
Latest Information Update: 08 Apr 2018
At a glance
- Drugs CHF 5633 (Primary) ; Poractant alfa
- Indications Neonatal respiratory distress syndrome
- Focus Therapeutic Use
- Sponsors Chiesi Farmaceutici
- 19 Mar 2018 Planned End Date changed from 1 May 2020 to 1 Sep 2020.
- 19 Mar 2018 Planned primary completion date changed from 1 Feb 2018 to 1 May 2018.
- 12 Jan 2017 Planned End Date changed from 1 Jan 2019 to 1 May 2020.