Trial Profile

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)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 13 Dec 2023

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At a glance

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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