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

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 3

Conditions: Acute Bacterial Gastroenteritis

Treatments: Drug: prulifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448422

OPT-099-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of acute bacterial gastroenteritis
• Traveler from an industrialized country
• Capable of giving Informed Consent

Exclusion criteria

• 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
• Bloody Diarrhea
• 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
• Antimicrobial treatment within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Tablet

Treatment:

Drug: prulifloxacin

2

Placebo Comparator group

Description:

Tablet

Treatment:

Drug: prulifloxacin