A comparison of three medications to treat diarrhea in adults.
This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
415
Oral, 2 caplets taken initially at investigator site followed by one caplet after each unformed stool, maximum 4 caplets in a 24 hour period for a maximum of 48 hours (per product label)
Oral, 2 chewable tablets taken initially at the site followed by one chewable tablet after each unformed stool, maximum 4 chewable tablets in a 24 hour period for a maximum of 48 hours (per product label)
Oral, 1 capsule twice a day, maximum 2 capsules in a 24 hour period for a maximum of 5 days (per product label)
Manipal Goa Hospital
Mormugao, Goa, India
Vrundavan Hospital & Research Centre
Mormugao, Goa, India
North West Medical
San José del Cabo, Baja California Sur, Mexico
Dr. Maxwell´s Clinic
San Miguel de Allende, Guanuajuato, Mexico
Number of unformed stools
Time frame: 0-24 hours
Number of unformed stools
Time frame: 0-12, 12-24, 24-36, 36-48 hours
Time to last unformed stool
Time frame: Throughout duration of the study
Time to complete relief of abdominal discomfort
Time frame: Throughout duration of the study
Time to complete relief of diarrhea
Time frame: Throughout duration of the study
Proportion of subjects with complete relief of diarrhea
Time frame: 4, 8, 12, 24 and 48 hours
Gas-related abdominal discomfort ratings - change from baseline at subsequent time points
Time frame: Throughout duration of the study
Proportions of subjects with complete well-being
Time frame: at 12, 24 and 48 hours.
Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief
Time frame: Throughout duration of the study
Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study
Time frame: Throughout duration of the study
Frequency of complete well-being following diarrhea illness
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Hospital Amerimed Puerto Vallarta
Puerto Vallarta, Jalisco, Mexico
Servicios Medicos de la Bahia
Puerto Vallarta, Jalisco, Mexico
Time frame: at 7 days follow up
Stool frequency
Time frame: at 7 days follow up
Frequency of diarrhea relapse
Time frame: at 7 days follow up
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study (+ 30 days for spontaneously-reported SAEs)