drugset / Trial / NCT00448422

Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers

NCT00448422

Phase 3 Completed 268 enrolled Optimer Pharmaceuticals LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.

Timeline

Start
2006-12
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Prulifloxacin Small molecule

Indications