Efficacy of Racecadotril in Acute Watery Diarrhea in Children

April 12, 2012 updated by: Giuseppe Grandy, Centro Pediatrico Albina de Patino

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Centro Pediatrico Albina de Patino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute watery diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Racecadotril
intestinal antisecretory
Drug: Racecadotril
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
Other Names:
  • Hidrasec
Placebo Comparator: cornstach solution
Cornstarch powder diluted in distilled water
Other: Placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
five days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Pediatrico Albina de Patino

Investigators

  • Study Director: Giuseppe Grandy, MD MSc, Centro Pediatrico Albina de Ptino
  • Principal Investigator: Richard Soria, MD, Centro Pediatrico Albina de Patino
  • Study Chair: Jackeline Torrez, MD, Centro Pediatrico Albina de Patino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protracec2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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