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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
  Purpose

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
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute watery diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577043

Locations
Bolivia
Centro Pediatrico Albina de Patino
Cochabamba, Bolivia
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Investigators
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

No publications provided

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

Keywords provided by Centro Pediatrico Albina de Patino:
acute diarrhea
Racecadotril
children

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Acetorphan
Thiorphan
 Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013