Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-06 @ 10:31 AM
Study NCT ID:
NCT04027894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-27
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Efficacy of Rifamycin SV MMX in Treating Traveler's Diarrhea in Children Age 12 to 17 Years
Sponsor:
RedHill Biopharma Limited
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: