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Completed

NCT Number: NCT00392574

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

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.

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Key information

Conditions

Acute Gastroenteritis in Adult Travelers Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INC Research

New Hope, Pennsylvania, 18938, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prulifloxacin

Drug

Tablet

Placebo

Drug

Tablet

Primary outcomes

  1. Time to last unformed stool

    Time frame: Study days 1-3

Secondary outcomes

  1. Clinical cure based on relief of signs and symptoms

    Time frame: Study days 1-3

  2. Microbiologic eradication rates

    Time frame: Study days 1-3

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 26, 2006
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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