NCT01577043

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centro Pediatrico Albina de Patino · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Diarrhea
• Acute Gastroenteritis

Interventions

Type	Name	Description
DRUG	Racecadotril	Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
OTHER	Placebo	cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-01-01
• Completion: 2012-04-01
• First posted: 2012-04-13
• Last updated: 2012-04-13

Locations

1 site across 1 country: Bolivia