Status:
COMPLETED
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Acute Gastroenteritis in Adult Travelers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subjects with acute bacterial gastroenteritis.
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 s...
Eligibility Criteria
Inclusion
- Diagnosis of Acute Bacterial Gastroenteritis;
- Traveler from Industrialized Country;
- Capable of giving Informed Consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00392574
Start Date
August 1 2006
End Date
March 1 2008
Last Update
May 15 2015
Active Locations (1)
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1
INC Research
New Hope, Pennsylvania, United States, 18938