Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577043
• Other study ID #: protracec2011
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2012
• Last updated: April 12, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2011
• Source: Centro Pediatrico Albina de Patino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Acute watery diarrhea

Exclusion Criteria:

• Severe malnourishment

• Severe dehydration

• Systemic infections

• Coinfections

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Diarrhea
• Acute Gastroenteritis
• Diarrhea
• Gastroenteritis

Intervention

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

Other:
• Placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

Locations

Country	Name	City	State
Bolivia	Centro Pediatrico Albina de Patino	Cochabamba

Sponsors (1)

Lead Sponsor	Collaborator
Centro Pediatrico Albina de Patino

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrheal episode	Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days	five days	Yes
Secondary	Duration of hospitalization	Participants was followed for the duration of hospitalization, we expected average of 5 days	five days	Yes
Secondary	Weight of stool	We expected the weight of the stool will diminish by about 5 days	five days	Yes
Secondary	Frequency of stool per day	We expected the frequency of stool will diminish by about 5 days	five days	Yes