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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2017

At a glance

  • Drugs Fidaxomicin (Primary) ; Vancomycin
  • Indications Clostridium 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.
    • 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.
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