Efficacy of Racecadotril in Acute Watery Diarrhea in Children

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01577043

Enrollment

Registered

2012-04-13

Start date

2011-09-30

Completion date

2012-04-30

Last updated

2012-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diarrhea, Acute Gastroenteritis

Keywords

acute diarrhea, Racecadotril, children

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.

Interventions

DRUGRacecadotril

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

* Acute watery diarrhea

Exclusion criteria

* Severe malnourishment * Severe dehydration * Systemic infections * Coinfections

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026