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

Phase 3

Completed

• Conditions: Acute Bacterial Gastroenteritis
• Interventions: Drug: prulifloxacin

• Registration Number: NCT00448422
• Lead Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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 patients with acute bacterial gastroenteritis (traveler's diarrhea.

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 other gastrointestinal-related symptoms, or tenesmus of \<72 hours duration.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2010-08-27
• Disposition First Posted: 2010-08-31
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-22
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	prulifloxacin	Tablet
2	prulifloxacin	Tablet

Primary Outcome Measures

Name	Time	Method
Time to Last Unformed Stool (TLUS)	End of Therapy

Secondary Outcome Measures

Name	Time	Method
Clinical cure based on relief of signs and symptoms	End of therapy/study
Microbiologic eradication rates	End of therapy/study

Trial Locations

Locations (1)

Goa Medical College; 🇮🇳 Bambolim, Goa, India