A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
Phase of Trial: Phase III
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Fidaxomicin (Primary) ; Vancomycin
- Indications Clostridium infections; Diarrhoea
- Focus Registrational; Therapeutic Use
- Acronyms SUNSHINE
- Sponsors Astellas Pharma Europe Ltd
- 11 Aug 2017 Planned End Date changed from 10 Jan 2018 to 1 Jan 2018.
- 11 Aug 2017 Planned primary completion date changed from 11 Dec 2017 to 1 Dec 2017.
- 20 Apr 2017 Planned End Date changed from 1 Jul 2017 to 10 Jan 2018.