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

Phase 3

Completed

• Conditions: Acute Gastroenteritis in Adult Travelers
• Interventions: Drug: Placebo; Drug: Prulifloxacin

• Registration Number: NCT00392574
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Status Verified: 2010-08
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2010-08-27
• Disposition First Posted: 2010-08-31
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Prulifloxacin	Prulifloxacin

Primary Outcome Measures

Name	Time	Method
Time to last unformed stool	Study days 1-3

Secondary Outcome Measures

Name	Time	Method
Clinical cure based on relief of signs and symptoms	Study days 1-3
Microbiologic eradication rates	Study days 1-3

Trial Locations

Locations (1)

INC Research; 🇺🇸 New Hope, Pennsylvania, United States