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

A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448422

Enrollment

268

Registered

2007-03-16

Start date

2006-12-31

Completion date

2008-08-31

Last updated

2010-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Gastroenteritis

Keywords

Traveler's, Diarrhea

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.

Interventions

DRUGprulifloxacin

Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to Last Unformed Stool (TLUS)	End of Therapy

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026