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Efficacy of Racecadotril in Acute Watery Diarrhea in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Grandy, Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT01577043
First received: April 11, 2012
Last updated: April 12, 2012
Last verified: June 2011
History of Changes

April 11, 2012
April 12, 2012
September 2011
January 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01577043 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy of Racecadotril in Acute Watery Diarrhea in Children
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Acute Diarrhea
  • Acute Gastroenteritis
  • Drug: Racecadotril
    Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
    Other Name: Hidrasec
  • Other: Placebo
    cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
  • Active Comparator: Racecadotril
    intestinal antisecretory
    Intervention: Drug: Racecadotril
  • Placebo Comparator: cornstach solution
    Cornstarch powder diluted in distilled water
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute watery diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Bolivia
 
NCT01577043
protracec2011
No
Giuseppe Grandy, Centro Pediatrico Albina de Patino
Centro Pediatrico Albina de Patino
Not Provided
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
Centro Pediatrico Albina de Patino
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP