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OpenTrials
Completed

NCT Number: NCT00448422

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

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.

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Key information

Conditions

Acute Bacterial Gastroenteritis Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Goa Medical College

Bambolim, Goa, India

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 other gastrointestinal-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 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

Treatment and study plan

prulifloxacin

Drug

Tablet

Primary outcomes

  1. Time to Last Unformed Stool (TLUS)

    Time frame: End of Therapy

Secondary outcomes

  1. Microbiologic eradication rates

    Time frame: End of therapy/study

  2. Clinical cure based on relief of signs and symptoms

    Time frame: End of therapy/study

Sponsors and collaborators

Lead sponsor

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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
Mar 16, 2007
Registry last updated
Sep 27, 2010

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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