OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

Trial Profile

OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2016

At a glance

  • Drugs Fidaxomicin (Primary) ; Vancomycin
  • Indications Clostridium infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 27 Sep 2016 Status changed from recruiting to completed.
    • 03 Feb 2016 Planned End Date changed from 1 Mar 2016 to 1 Dec 2016, according to ClinicalTrials.gov record.
    • 03 Feb 2016 Planned primary completion date changed from 1 Mar 2016 to 1 Dec 2016, according to ClinicalTrials.gov record.
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