Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
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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.
Condition or disease
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 other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of acute bacterial gastroenteritis
Traveler from an industrialized country
Capable of giving Informed Consent
Fever (>100.3 degrees)
Pregnant or Breast Feeding or Not using adequate birth control
Known or Suspected (co-)Infection with non-bacterial pathogen
Symptoms of acute gastroenteritis of >72 hours duration
Concomitant antibacterial with activity against enteric bacterial pathogens
History of IBD
Unable/Unwilling to comply with study protocol
Greater than two doses of an antidiarrheal medication within 24 hours
> 2 doses of anti-diarrheal medication within 24 hours