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Randomised controlled trial (RCT).
Computer-generated block randomisation.
Open-label (not explicitly stated).
Spanish tertiary paediatric accident and emergency department
A total of 189 children aged 3–36 months with acute gastroenteritis, defined as at least three loose stools within the preceding 24 h. Patients who had symptoms for more than 7 days, and those requiring hospitalisation were excluded.
Of the 179 patients that were included in the efficacy analysis, 91 received standard oral rehydration solution (ORS) while 88 received ORS plus racecadotril (ORS+R). Racecadotril treatment was discontinued when the patient had two stools of normal consistency, or no bowel movement in the preceeding 12 h. Patients were re-assessed after 48 h and at 7 days.
The primary outcome was reduction of bowel movements within 48 h of initiating therapy. Secondary outcomes were duration of diarrhoea, number of doctor visits in the interim and safety and tolerability of the study drug.
One week in total. High proportion of drop-outs: 137/189 (72%) patients returned …
Sources of funding The manufacturer of racecadotril (Ferrer Internacional) provided funding for the study (including for study drugs and statistical analysis).
Provenance and peer review Commissioned; not externally peer reviewed.