Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Phase 4

Completed

• Conditions: Acute Diarrhea; Acute Gastroenteritis
• Interventions: Other: Placebo; Drug: Racecadotril

• Registration Number: NCT01577043
• Lead Sponsor: Centro Pediatrico Albina de Patino

Brief 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.

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-09
• Primary Completion: 2012-01
• Study Completion: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-12
• Last Update Submitted: 2012-04-12
• Study First Posted: 2012-04-13
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Acute watery diarrhea

Exclusion Criteria

• Severe malnourishment
• Severe dehydration
• Systemic infections
• Coinfections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cornstach solution	Placebo	Cornstarch powder diluted in distilled water
Racecadotril	Racecadotril	intestinal antisecretory

Primary Outcome Measures

Name	Time	Method
Duration of diarrheal episode	five days	Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	five days	Participants was followed for the duration of hospitalization, we expected average of 5 days
Weight of stool	five days	We expected the weight of the stool will diminish by about 5 days
Frequency of stool per day	five days	We expected the frequency of stool will diminish by about 5 days

Trial Locations

Locations (1)

Centro Pediatrico Albina de Patino; 🇧🇴 Cochabamba, Bolivia