Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Acute Gastroenteritis in Adult Travelers

Treatments: Drug: Placebo; Drug: Prulifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392574

OPT-099-001

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 subjects with acute bacterial gastroenteritis.

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 gas-related symptoms, or tenesmus of ≤72 hours duration.

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Acute Bacterial Gastroenteritis;
• Traveler from 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 Gastroenteritis of >72 hours;
• Bloody Diarrhea;
• Concomitant antibacterial with activity against enteric bacterial pathogens;
• History of IBD;
• Unable/Unwilling to comply with study protocol;
• > 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: Double Blind

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282 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Prulifloxacin

Treatment:

Drug: Prulifloxacin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo