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COMPARATIVE STUDY, MULTICIENTRIC, DOUBLE-BLIND, RANDOMIZED RIFAXIMIN VS. PLACEBO VS. CIPROFLOXACIN (CYPRUS) IN THE TREATMENT OF TRAVELER´S DIARRHEA CAUSED BY ENTEROPATHOGENIC ORGANISMS.

COMPARATIVE STUDY, MULTICIENTRIC, DOUBLE-BLIND, RANDOMIZED RIFAXIMIN VS. PLACEBO VS. CIPROFLOXACIN (CYPRUS) IN THE TREATMENT OF TRAVELER´S DIARRHEA CAUSED BY ENTEROPATHOGENIC ORGANISMS.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-007-03
Enrollment
Unknown
Registered
2003-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Rifaximin Type of group
One 200 mg tablet of rifaximin, plus one identical placebo capsule, will be administered three times a day for 3 days. Group name:Placebo Type of group
Two equal capsules will be administered three times a day for 3 days.

Sponsors

SANKYO PHARMA DEVELOPMENT,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects of male or female sex 18 years of age or older. A minimum of three stool stools not formed within 24 hours prior to randomization. Provide a sample of fecal matter prior to the study that is verified as not formed. Experience at least one of the signs or symptoms of enteric infection.

Exclusion criteria

Exclusion criteria: Acute diarrhea for more than 72 hours. Moderate or severe dehydration. Active, uncontrolled and / or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal tract

Design outcomes

Primary

MeasureTime frame
Outcome name:Interval that begins with the first dose of the clinical trial material and ends with the last evacuation of unformed stools. Measure:Duration of diarrhea after the start of study therapy, which will be measured using the time to the last stool stool not formed for rifaximin, compared to a placebo. Timepoints:for 5 days

Secondary

MeasureTime frame
Outcome name:The number of stool stools not formed evacuated by time interval Measure:The number of stool stools not formed evacuated by time interval Timepoints:for 5 days

Countries

Argentina, Guatemala, India, Mexico, Peru, Singapore

Outcome results

None listed

Source: REPEC (via WHO ICTRP)