Abstract | METHODS: A multicentre, parallel-group, double-blind, double-placebo study was carried out to compare the efficacy, tolerability, and safety of racecadotril and loperamide in children aged 2 to 10 years who were suffering from acute diarrhoea. Patients received racecadotril (1.5 mg/kg) or loperamide (0.03 mg/kg) three times daily plus matching placebo until recovery. Fifty-two children received racecadotril and 50 loperamide. RESULTS: Patients on racecadotril passed a mean (+/- S.E.M.) of 2.7 +/- 0.4 stools before recovery compared with 2.1 +/- 0.4 stools for loperamide. The duration of diarrhoea was similar with both treatments. The incidence of adverse events was lower with racecadotril than with loperamide (11.5% vs. 22%), and significantly more patients on loperamide suffered from constipation (58% vs. 36.5%; P = 0.03). Moreover, significantly more children receiving loperamide required concomitant medication during the study (38% v 19.2%; P = 0.047). Measurement of abdominal circumference at the final consultation, 6 days after entry to the study, revealed no significant differences between treatments. CONCLUSIONS:
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Authors | D Turck, H Berard, N Fretault, J M Lecomte |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 13 Suppl 6
Pg. 27-32
(Dec 1999)
ISSN: 0269-2813 [Print] England |
PMID | 10646049
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antidiarrheals
- Protease Inhibitors
- Loperamide
- racecadotril
- Thiorphan
- Neprilysin
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Topics |
- Acute Disease
- Antidiarrheals
(therapeutic use)
- Child
- Child, Preschool
- Diarrhea
(drug therapy)
- Double-Blind Method
- Female
- Humans
- Loperamide
(adverse effects, therapeutic use)
- Male
- Neprilysin
(antagonists & inhibitors)
- Protease Inhibitors
(therapeutic use)
- Recurrence
- Thiorphan
(adverse effects, analogs & derivatives, therapeutic use)
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