Status:
COMPLETED
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
Lead Sponsor:
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Acute Bacterial Gastroenteritis
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 patients with acute bacterial gastroenteritis (traveler's di...
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 an 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 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00448422
Start Date
December 1 2006
End Date
August 1 2008
Last Update
September 27 2010
Active Locations (1)
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1
Goa Medical College
Bambolim, Goa, India