Racecadotril for Acute Diarrhea in Infants, Children and Adolescents: An Open-Label Clinical Study in Russia - Abstract
Objectives: This study evaluated the efficacy and safety of racecadotril together with oral rehydration solution (ORS) compared to ORS alone in infants (>3 months), children and adolescents with acute diarrhea. ClinicalTrials.gov Identifier: NCT03463512.
Methods: A controlled, open-label, parallel-group multicentre study in which a total of 124 children and adolescents aged 3 months to <18 years (n=62 per treatment group), were randomized to treatment with oral racecadotril (1.5 mg/kg), t.i.d. for a maximum of 5 days plus ORS (RACE+ORS) or ORS alone. The primary endpoint was duration of diarrhea from the start of treatment until final diarrheal/watery stool before recovery or end of study treatment.
Results: The median duration of diarrhea was statistically significantly shorter with RACE+ORS compared to ORS (16.8 h vs 40.6 h; p<0.0001). The overall mean number of stools during the study decreased with RACE+ORS compared with ORS (5.9 vs 8.3), as did the mean number of watery stools (4.2 vs 6.5). All subjects (62/62; 100%) in the RACE+ORS group recovered by Day 6 compared to 58/62 (93.5%) with ORS. The median time to recovery was statistically significantly shorter with RACE+ORS compared with ORS (29.3 h vs 58.2 h; p<0.0001). The median duration of treatment was shorter with RACE+ORS (49.50 h) compared with ORS(67.08 h). No treatment emergent adverse events were reported in either treatment group.
Conclusions: Racecadotril plus ORS was significantly more effective for the treatment of acute diarrhea than ORS alone in children aged 3 months to <18 years and was well tolerated.