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Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Primary Purpose

Acute Diarrhea, Acute Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Bolivia
Study Type
Interventional
Intervention
Racecadotril
Placebo
Sponsored by
Centro Pediatrico Albina de Patino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Diarrhea focused on measuring acute diarrhea, Racecadotril, children

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute watery diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections

Sites / Locations

  • Centro Pediatrico Albina de Patino

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Racecadotril

cornstach solution

Arm Description

intestinal antisecretory

Cornstarch powder diluted in distilled water

Outcomes

Primary Outcome Measures

Duration of diarrheal episode
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
Participants was followed for the duration of hospitalization, we expected average of 5 days
Weight of stool
We expected the weight of the stool will diminish by about 5 days
Frequency of stool per day
We expected the frequency of stool will diminish by about 5 days

Full Information

First Posted
April 11, 2012
Last Updated
April 12, 2012
Sponsor
Centro Pediatrico Albina de Patino
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1. Study Identification

Unique Protocol Identification Number
NCT01577043
Brief Title
Efficacy of Racecadotril in Acute Watery Diarrhea in Children
Official Title
Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Pediatrico Albina de Patino

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea, Acute Gastroenteritis
Keywords
acute diarrhea, Racecadotril, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Racecadotril
Arm Type
Active Comparator
Arm Description
intestinal antisecretory
Arm Title
cornstach solution
Arm Type
Placebo Comparator
Arm Description
Cornstarch powder diluted in distilled water
Intervention Type
Drug
Intervention Name(s)
Racecadotril
Other Intervention Name(s)
Hidrasec
Intervention Description
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
Primary Outcome Measure Information:
Title
Duration of diarrheal episode
Description
Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
Time Frame
five days
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Description
Participants was followed for the duration of hospitalization, we expected average of 5 days
Time Frame
five days
Title
Weight of stool
Description
We expected the weight of the stool will diminish by about 5 days
Time Frame
five days
Title
Frequency of stool per day
Description
We expected the frequency of stool will diminish by about 5 days
Time Frame
five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute watery diarrhea Exclusion Criteria: Severe malnourishment Severe dehydration Systemic infections Coinfections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandy, MD MSc
Organizational Affiliation
Centro Pediatrico Albina de Ptino
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard Soria, MD
Organizational Affiliation
Centro Pediatrico Albina de Patino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jackeline Torrez, MD
Organizational Affiliation
Centro Pediatrico Albina de Patino
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Pediatrico Albina de Patino
City
Cochabamba
Country
Bolivia

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

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