A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea (CDAD)
Phase of Trial: Phase III
Latest Information Update: 31 Jul 2017
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.
- 29 Jun 2012 Companies added in the association field as reported by EudraCT.
- 16 Jun 2012 Results presented at the 15th International Congress on Infectious Diseases.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History