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Pharmacokinetics, Safety, and Efficacy of Xifaxan in Pediatric Subjects With Acute Diarrhea
NCT07285785Phase 4
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- Apr 2027
- Countries
- 1
- Sponsor
- Valeant Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- rifaximin
- Conditions
- acute diarrhea
01
Overview
Phase 4, randomised, open-label trial of rifaximin in acute diarrhea (2 arms), sponsored by Valeant Pharmaceuticals. Primary endpoints: Peak Plasma Concentration of Rifaximin at Day 3, Time to Maximum Plasma Concentration of Rifaximin at Day 3 and 3 more. Started Feb 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Rifaximin 200 mg + ORT
Xifaxan 200 mg tablets orally three times daily for 3 days plus oral rehydration therapy (ORT)
ORT Alone
Oral rehydration therapy (ORT) administered per investigator standard of care without rifaximin
03
Who it enrols
Pediatric patients aged 6-11 years weighing at least 15 kg with acute diarrhea of suspected bacterial etiology, excluding those with chronic diarrhea, severe bacterial diarrhea, or recent use of anti-diarrheals or antimicrobials.
04
Endpoints
Primary
Peak Plasma Concentration of Rifaximin
Time to Maximum Plasma Concentration of Rifaximin
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration for Rifaximin
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval for Rifaximin
Proportion of participants with Clinical Cure
Secondary
Time to Last Unformed Stool
Incidence of Treatment-Emergent Adverse Events
Change From Baseline in Clinical Laboratory Parameters
Change From Baseline in Vital Signs
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