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Clinical Trial 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.


Clinical Trial Description

Approximately 142 subjects are expected to be enrolled in the study, 1:1 in the Rifamycin SV MultiMatrix (MMX) plus Oral Rescue Therapy (ORT) group and in the placebo tablets plus ORT group respectively. The day of randomization (Visit 1, Day 1), the subjects will start the treatment receiving ORT plus Rifamycin SV MMX 100 mg (as two tablets of 50 mg each) twice daily (morning and evening) or ORT plus placebo tablets (as two tablets) twice daily (morning and evening). The subjects will begin the treatment within 72 hours of onset of diarrhea. Treatment duration will last 72 hours. The total number of tablets for the entire treatment course will be 12 (4 × 50 mg tablets/day for 3 days). The administration of the ORT will follow the specification reported in the product label. The tablets will be orally administered during the day. No tablet administration will be done during the night. After enrollment, subjects/their parents/or guardians will complete Diary cards (PDC) in which will be daily recorded date, time of first tablets intake, time and consistency of each stool, presence of blood in stools, abdominal pain/cramps, flatulence, tenesmus, urgency, nausea, vomiting, fever, adverse events (AEs), and concomitant medications. During the study, the subjects will be assessed for safety and efficacy at Visit 2 (Day 2) and Visit 3 (Day 4/5) as final Study Visit. Stool samples for microbiological assessment will be collected at Visits 1 and 3. Stool will be examined and cultured at local labs for main enteropathogens and for the presence of protozoa, ova and yeasts. Blood and urine sampling for routine safety analyses will be collected at Visit 1 and at Visit 3. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04026984
Study type Interventional
Source RedHill Biopharma Limited
Contact Gilead Raday
Phone +972-3-6398893
Email gilead@redhillbio.com
Status Not yet recruiting
Phase Phase 2
Start date June 2024
Completion date December 2025

See also
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Completed NCT00672035 - Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study Phase 2
Completed NCT01208922 - Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea Phase 3
Completed NCT01142089 - Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD) Phase 3
Not yet recruiting NCT04027894 - Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years Phase 2
Completed NCT03866291 - ESBL in Patients Returning to Sweden With Traveller's Diarrhoea
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Completed NCT01040325 - Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study Phase 2
Withdrawn NCT02736539 - Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea Phase 3