Table 2 Reported efficacy parameters in randomized studies with racecadotril in the treatment of acute diarrhea in children. Note that most studies have reported multiple endpoints but only 12 had a pre-specified primary endpoint. For details see main text
Efficacy parameter | Number of studies total | Number of studies as primary endpoint |
|---|---|---|
Global and qualitative efficacy parameters | ||
 Day 3 cure/improved/no change | 11 | – |
 Day 3 markedly effective/effective/ineffective | 30 | – |
 Day 5 markedly effective/effective/ineffective | 2 | – |
Stool number, quality and amount | ||
 24 h number of stools | 9 | – |
 48 h number of stools | 12 | 4 |
 72 h number of stools | 4 | – |
 7–10 day number of stools | 2 | – |
 Total number of stools until cure | 3 | 1 |
 24 h stool output (g) | 2 | – |
 48 h stool output (g) | 3 | 3 |
 Total stool output (g) until cure | 2 | – |
 48 h % of patients with watery stools | 2 | – |
 Day 5 negative stool culture | 1 | – |
 Day 7 % of patients with solid stool | 1 | – |
 Kaplan-Meier analysis of unresolved diarrhea over time | 2 | – |
Measures of duration of disease and fluid replacement | ||
 Total duration of diarrhea (incl. Pre-treatment) | 7 | – |
 Time to cure | 22 | 3 |
 Day 1 cure rate | 1 | – |
 Day 2 cure rate | 3 | – |
 Day 3 cure rate | 41 | – |
 Day 5 cure rate | 4 | – |
 Day 7 cure rate | 4 | – |
 Duration of fever | 2 | – |
 Time to correction of dehydration | 2 | – |
 Day 2 need for ORT | 1 | – |
 Day 3 need for ORT | 1 | – |
 Total volume of ORT requirement | 4 | – |
 Need for unscheduled IRT | 2 | – |
 Duration of treatment | 6 | – |
Doctor visits and social outcomes | ||
 2nd emergency room visit | 3 | 1 |
 Day 2 emergency room visit | 1 | – |
 Day 7 emergency room visit | 1 | – |
 Number of doctor visits during follow-up | 1 | – |
 Duration of hospitalization | 4 | – |
 % hospitalized after 24 h | 1 | – |
 % hospitalized after 48 h | 1 | – |
 Need for secondary hospitalization | 1 | – |
 Nursery/school attendance | 1 | – |
 Degree of patient satisfaction | 1 | – |
Other efficacy parameters | ||
 % resolution of vomiting | 1 | – |
 Need for additional medication | 1 | – |
 Body weight at end of treatment | 1 | – |
 Na+/K+ ratio in urine | 1 | – |
 IL-1, IL-8 and IL-12 in serum | 1 | – |
 Recurrence rate | 1 | – |