Efficacy of Racecadotril in Acute Watery Diarrhea in Children
NCT ID: NCT01577043
Last Updated: 2012-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2011-09-30
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Racecadotril
intestinal antisecretory
Racecadotril
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
cornstach solution
Cornstarch powder diluted in distilled water
Placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
Interventions
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Racecadotril
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
Placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe dehydration
* Systemic infections
* Coinfections
6 Months
59 Months
ALL
No
Sponsors
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Centro Pediatrico Albina de Patino
OTHER
Responsible Party
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Giuseppe Grandy
Medical Chief of Nutrition Center
Principal Investigators
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Giuseppe Grandy, MD MSc
Role: STUDY_DIRECTOR
Centro Pediatrico Albina de Ptino
Richard Soria, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Pediatrico Albina de Patino
Jackeline Torrez, MD
Role: STUDY_CHAIR
Centro Pediatrico Albina de Patino
Locations
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Centro Pediatrico Albina de Patino
Cochabamba, Departamento de Cochabamba, Bolivia
Countries
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Other Identifiers
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protracec2011
Identifier Type: -
Identifier Source: org_study_id
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