At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 31 enrolled

Drug / intervention

Racecadotril plus ORSdrug

Likely dose

Racecadotril plus ORS 1.5 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03473561

NCT03473561Phase 3Completed

Compare CT.gov

Efficacy and Safety of Racecadotril in the Treatment of Taiwanese Children Aged 3 to 60 Months Suffering From Acute Diarrhea: A Prospective, Open-label, Multicenter, Single-arm Study.

Abbott·interventional·Posted Mar 22, 2018·Updated Nov 24, 2023

In Brief

A Phase 3 clinical trial evaluating Racecadotril plus ORS for Diarrhea, Infantile. Completed, enrolled 31 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiarrhea, Infantile

CountriesTaiwan

Collaborators--

Timeline

Phase 3CompletedFinished

201820192020202120222023202420252026

First PostedMar 2018

Enrollment StartAug 2018

Primary CompletionJan 2020

TodayJul 2026

First PostedMar 22, 2018

Enrollment StartAug 25, 2018

Primary CompletionJan 8, 2020

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 8.3 years ago

Interventions

Racecadotril plus ORSdrug

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.