Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Centro Pediatrico Albina de Patino

Status and phase: Completed; Phase 4

Conditions: Acute Gastroenteritis; Acute Diarrhea

Treatments: Drug: Racecadotril; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01577043

protracec2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute watery diarrhea

Exclusion criteria

• Severe malnourishment
• Severe dehydration
• Systemic infections
• Coinfections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Racecadotril

Active Comparator group

Description:

intestinal antisecretory

Treatment:

Drug: Racecadotril

cornstach solution

Placebo Comparator group

Description:

Cornstarch powder diluted in distilled water

Treatment:

Other: Placebo