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Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years

NCT04027894 · 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 12-17) 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

200 mg Rifamycin SV-MMX® (CB-01-11)

DRUG

Placebo to Rifamycin SV-MMX

Placebo to Rifamycin SV-MMX® Placebo tablets correspond to active tablets with respect to size, taste, and appearance.

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
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-01-31
Completion
2025-12-31
FDA Drug
Yes

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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 NCT04027894 on ClinicalTrials.gov