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