The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
282
Tablet
Tablet
INC Research
New Hope, Pennsylvania, United States
Time to last unformed stool
Time frame: Study days 1-3
Clinical cure based on relief of signs and symptoms
Time frame: Study days 1-3
Microbiologic eradication rates
Time frame: Study days 1-3
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