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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Gastroenteritis in Adult Travelers

In brief

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.

Key facts

Study ID

NCT00392574

Run by

Merck Sharp & Dohme LLC

People needed

282

Starts

2006-08-01

Expected to finish

2008-03-01

Last updated by the study team

2015-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Acute Bacterial Gastroenteritis;
• Traveler from Industrialized Country;
• Capable of giving Informed Consent

You may not qualify if…

• 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

Where it is running

• INC Research — New Hope, Pennsylvania, United States

Full record on ClinicalTrials.gov

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