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

NCT00392574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2015-05-15

No results posted yet for this study

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.

Conditions

  • Acute Gastroenteritis in Adult Travelers

Interventions

DRUG

Prulifloxacin

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

Principal Investigators

  • Herbert Dupont, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392574 on ClinicalTrials.gov