Adults 3 Months to 17, any sex, with Diarrhea. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days)Primary· 5 days
Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary.
Log-rank test was performed with a p-value \< 0.0001
Group
Value
95% CI
Racecadotril Plus Standard Treatment Oral Rehydration Solution
20.0
± 2.2
ORS (Standard Treatment)
43.2
± 3.4
Number of Recovered Subjects Per Treatment Group.Secondary· 5 days
Number of recovered subjects per treatment group. Recovery is defined as the evacuation of the first of two consecutive normal stools or no stool within 12 h within treatment period
Group
Value
95% CI
Racecadotril Plus Standard Treatment Oral Rehydration Solution
62
ORS (Standard Treatment)
58
Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of TreatmentSecondary· 5 days
Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment success
Group
Value
95% CI
Racecadotril Plus Standard Treatment Oral Rehydration Solution
62
ORS (Standard Treatment)
60
Sponsor's own description
Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03473561 — Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott
Last refreshed: 23 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03463512.