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.
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 other gastrointestinal-related symptoms, or tenesmus of \<72 hours duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
268
Tablet
Goa Medical College
Bambolim, Goa, India
Time to Last Unformed Stool (TLUS)
Time frame: End of Therapy
Microbiologic eradication rates
Time frame: End of therapy/study
Clinical cure based on relief of signs and symptoms
Time frame: End of therapy/study
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