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Evaluate Safety and Efficacy of Rifamycin SV MMX in the Treatment of Traveler's Diarrhea in Children Age 6 to 11 Years

NCT04026984 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Traveler's Diarrhea

Interventions

DRUG

Rifamycin SV-MMX

2 Rifamycin SV-MMX® 50 mg tablets b.i.d. plus ORT

DRUG

Placebo

Matching Placebo tablets

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • June Almenoff, MD, PhD · RedHill Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04026984 on ClinicalTrials.gov