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Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

NCT03473561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-11-24

Study results available
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Summary

This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute diarrhea

Conditions

  • Diarrhea, Infantile

Interventions

DRUG

Racecadotril plus ORS

1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution). In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to \< 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-25
Primary Completion
2020-01-08
Completion
2020-01-08

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473561 on ClinicalTrials.gov