Trial Profile
A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 13 Dec 2023
Price :
$35
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At a glance
- Drugs Fidaxomicin (Primary) ; Vancomycin
- Indications Clostridium difficile infections; Diarrhoea
- Focus Registrational; Therapeutic Use
- Sponsors Optimer Pharmaceuticals
- 26 Apr 2013 Australian Therapeutic Goods Administration approved fidaxomicin for Clostridium difficile infection based on this trial, according to an Optimer Pharmaceuticals media release.
- 30 Mar 2012 A post-hoc subgroup analysis is being presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2012)
- 10 May 2011 Pooled pharmacokinetic analysis results presented at Digestive Disease Week 2011.