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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children|
- Duration of diarrheal episode [ Time Frame: five days ] [ Designated as safety issue: Yes ]Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
- Duration of hospitalization [ Time Frame: five days ] [ Designated as safety issue: Yes ]Participants was followed for the duration of hospitalization, we expected average of 5 days
- Weight of stool [ Time Frame: five days ] [ Designated as safety issue: Yes ]We expected the weight of the stool will diminish by about 5 days
- Frequency of stool per day [ Time Frame: five days ] [ Designated as safety issue: Yes ]We expected the frequency of stool will diminish by about 5 days
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Racecadotril
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
Other Name: Hidrasec
Placebo Comparator: cornstach solution
Cornstarch powder diluted in distilled water
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577043
|Centro Pediatrico Albina de Patino|
|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|