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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History