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Efficacy of Racecadotril in Acute Watery Diarrhea in Children

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

Condition Intervention Phase
Acute Diarrhea
Acute Gastroenteritis
Drug: Racecadotril
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children

Resource links provided by NLM:

Further study details as provided by Centro Pediatrico Albina de Patino:

Primary Outcome Measures:
  • Duration of diarrheal episode [ Time Frame: five days ]
    Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days

Secondary Outcome Measures:
  • Duration of hospitalization [ Time Frame: five days ]
    Participants was followed for the duration of hospitalization, we expected average of 5 days

  • Weight of stool [ Time Frame: five days ]
    We expected the weight of the stool will diminish by about 5 days

  • Frequency of stool per day [ Time Frame: five days ]
    We expected the frequency of stool will diminish by about 5 days

Enrollment: 52
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Racecadotril
intestinal antisecretory
Drug: 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
Other: Placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

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.


Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute watery diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections
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Please refer to this study by its identifier: NCT01577043

Centro Pediatrico Albina de Patino
Cochabamba, Bolivia
Sponsors and Collaborators
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
  More Information

Responsible Party: Giuseppe Grandy, Medical Chief of Nutrition Center, Centro Pediatrico Albina de Patino Identifier: NCT01577043     History of Changes
Other Study ID Numbers: protracec2011
Study First Received: April 11, 2012
Last Updated: April 12, 2012

Keywords provided by Centro Pediatrico Albina de Patino:
acute diarrhea

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017