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Prulifloxacin for Acute Gastroenteritis in Travelers
NCT00448422Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Aug 2008
- Countries
- 1
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- prulifloxacin
- Conditions
- traveler's diarrhea (TD)
01
Overview
Phase 3, randomised, double-blind trial in traveler's diarrhea (TD) comparing Prulifloxacin with Placebo (2 arms). Primary endpoint: Time to Last Unformed Stool. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Prulifloxacin
Prulifloxacin tablets
Placebo
Placebo tablets
03
Who it enrols
Adult travelers with acute bacterial gastroenteritis (traveler's diarrhea) of <72 hours duration, excluding those with fever >100.3 F, bloody diarrhea, or history of IBD.
04
Endpoints
Primary
Time to Last Unformed Stool
Secondary
Microbiologic eradication rates
Clinical cure based on relief of signs and symptoms
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