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Double Blind, Multi-center Study to Evaluate the Safety and Efficacy of 100 mg Twice Daily Rifamycin SV MMX® Added to Standard ORT Versus Placebo Plus ORT, in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years
This will be a double-blind comparative study, performed in pediatric subjects (Age 6-11) traveling to developing regions with a known high incidence of traveler's diarrhea. The subjects will be suffering from acute diarrhea for at least 12 hours, without symptoms of systemic infection.
Details
| Lead sponsor | RedHill Biopharma Limited |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 142 |
| Start date | 2024-06 |
| Completion | 2025-12 |
Conditions
- Traveler's Diarrhea
Interventions
- Rifamycin SV-MMX
- Placebo
Primary outcomes
- Clinical Cure — 120 hours
Passage of two or fewer soft stools and no watery stools, no fever (\> 100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24-hour interval in the 120-hour data collection period after the first dose of study drug or Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hour data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection.