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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)

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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

  • Drugs Fidaxomicin (Primary) ; Vancomycin
  • Indications Clostridium difficile infections; Diarrhoea
  • Focus Registrational; Therapeutic Use
  • Sponsors Optimer Pharmaceuticals

    • Most Recent Events

    • 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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