A multicenter, double-blind, randomized study to compare the safety and efficacy of prulifloxacin versus placebo in the treatment of acute gastroenteritis in adult travelers

Trial Profile

A multicenter, double-blind, randomized study to compare the safety and efficacy of prulifloxacin versus placebo in the treatment of acute gastroenteritis in adult travelers

Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2015

At a glance

  • Drugs Prulifloxacin (Primary)
  • Indications Traveller's diarrhoea
  • Focus Registrational; Therapeutic Use
  • Sponsors Optimer Pharmaceuticals
  • Most Recent Events

    • 11 Oct 2010 An NDA is expected to be submitted to the US FDA in the first quarter of 2011, according to an Optimer Pharmaceuticals media release.
    • 25 Feb 2009 Primary endpoint 'Time to last unformed stool' has been met.
    • 25 Feb 2009 Results have been reported in an Optimer Pharmaceuticals media release; it is expected that these reults along with those from trial OPT099-002 will be adequate to support an NDA filing.
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