NCT04027894

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

Double Blind Study to Evaluate the Safety and Efficacy of 400 mg Twice Daily Rifamycin SV MMX® Added to Standard Oral Rehydration Therapy (ORT) Versus Placebo Plus ORT, in the Treatment of Traveler's Diarrhea in Children Age 12 to 17 Years

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: RedHill Biopharma Limited · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 142 subjects are expected to be enrolled in the study, 1:1 in the Rifamycin SV MultiMatrix (MMX) plus Oral RehydrationTherapy (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 400 mg (as two tablets of 200 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 × 200 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. Stool samples will be required in a subset population of the Rifamycin SV MMX group, at the Follow-up visit to determine rifamycin concentration in the feces. Blood and urine sampling for routine safety analyses will be collected at Visit 1 and at Visit 3.

Conditions

• Traveler's Diarrhea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2019-07-22
• Last updated: 2023-01-27

Regulatory

• FDA-regulated drug study