For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.
A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico
Evaluate Multiple Endpoints
Time frame: 6 hours
Time to improvement in stool form
Time frame: 6 hours
Time to improvement in urge to defecate
Time frame: 6 hours
Time to improvement in gas-related abdominal discomfort
Time frame: 6 hours
Time to improvement of change in normal activities of daily living
Time frame: 6 hours
Subject global impression of efficacy of study medication at the end of the treatment period
Time frame: 6 hours
Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study
Time frame: 6 hours
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