NCT01577043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
Last Updated

April 13, 2012

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

April 11, 2012

Last Update Submit

April 12, 2012

Conditions

Acute DiarrheaAcute Gastroenteritis

Keywords

acute diarrheaRacecadotrilchildren

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrheal episode

    Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days

    five days

Secondary Outcomes (3)

  • Duration of hospitalization

    five days

  • Weight of stool

    five days

  • Frequency of stool per day

    five days

Study Arms (2)

Racecadotril

ACTIVE COMPARATOR

intestinal antisecretory

Drug: Racecadotril

cornstach solution

PLACEBO COMPARATOR

Cornstarch powder diluted in distilled water

Other: Placebo

Interventions

RacecadotrilDRUG

Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day

Also known as: Hidrasec
Racecadotril
PlaceboOTHER

cornstarch powder diluted in distilled water, dosage 2.5 ml per dose

cornstach solution

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acute watery diarrhea

You may not qualify if:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • Coinfections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Pediatrico Albina de Patino

Cochabamba, Departamento de Cochabamba, Bolivia

Location

MeSH Terms

Interventions

racecadotril

Study Officials

  • Giuseppe Grandy, MD MSc

    Centro Pediatrico Albina de Ptino

    STUDY DIRECTOR

  • Richard Soria, MD

    Centro Pediatrico Albina de Patino

    PRINCIPAL INVESTIGATOR

  • Jackeline Torrez, MD

    Centro Pediatrico Albina de Patino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Chief of Nutrition Center

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

April 13, 2012

Record last verified: 2011-06

Locations

BO(1)