Acute Gastroenteritis Clinical Trial
Official title:
Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Background: Treatment of acute diarrhea is based on the following various oral rehydration
management guidelines. Lately other drugs currently under investigation as antisecretory
drugs to shorten the diarrheal episode and can be used safely in children.
Objectives: To evaluate the effect of racecadotril in the treatment of children under 5
years of age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have
two groups of patients: One group will receive racecadotril plus oral rehydration and the
other one will receive placebo plus oral rehydration; the parameters of evaluation are going
to be the duration of diarrheal episode, number of stools by day, weight of stool,
nutritional state.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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