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

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 travellers

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 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.
    • 09 Feb 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 14 Sep 2009 Results were presented at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2009 in San Francisco.
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