Skip to main content
OpenTrials
Completed

NCT Number: NCT01577043

Efficacy of Racecadotril in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Diarrhea Acute Gastroenteritis

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Pediatrico Albina de Patino

Cochabamba, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute watery diarrhea

Exclusion criteria

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections

Treatment and study plan

Racecadotril

Drug

Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day

Other names: Hidrasec

Placebo

Other

cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

Primary outcomes

  1. Duration of diarrheal episode

    Time frame: five days

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

Secondary outcomes

  1. Duration of hospitalization

    Time frame: five days

    Participants was followed for the duration of hospitalization, we expected average of 5 days

  2. Weight of stool

    Time frame: five days

    We expected the weight of the stool will diminish by about 5 days

  3. Frequency of stool per day

    Time frame: five days

    We expected the frequency of stool will diminish by about 5 days

Sponsors and collaborators

Lead sponsor

Centro Pediatrico Albina de Patino

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2012
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.