A
MULTICENTER RANDOMIZED CONTROLLED TRIAL OF A LIQUID LOPERAMIDE PRODUCT VERSUS
PLACEBO IN THE TREATMENT OF ACUTE DIARRHEA IN CHILDREN.
Kaplan
MA, et al. Clin Pediatr (Phila) 1999 Oct;38(10):579-91.
DESIGN:
This randomized, double-blind, placebo-controlled trial of 48 hours' duration
conducted in 13 primary care ambulatory practices in the United States and
Mexico was used to compare the efficacy and safety of loperamide with placebo
for the treatment of acute diarrhea in children aged 2 through 11 years.
RESULTS:
Two hundred fifty-eight children with acute nonspecific diarrhea were enrolled.
Children were randomly assigned to treatment with loperamide HCl 0.5 mg/5 mL (n
= 130) or placebo (n = 128). The first dose of loperamide consisted of either 1.0
mg (children 2 through 5 years of age) or 2.0 mg (children 6 through 11 years
of age) of study medication under the observation of study personnel. This was
followed by 1 mg after each unformed stool, with a total daily dose of up to
3.0 mg in the children 2-5 years of age, 4.0 mg in the children 6-8 years of
age, and 6.0 mg in the children 9-11 years of age. The primary outcome measures
were time to last unformed stool, time to first unformed stool, number of
unformed stools during six consecutive 8-hour periods, and overall rating of
efficacy/acceptability. Secondary outcomes included abdominal pain/cramping,
vomiting, and fever. Children who received loperamide had significantly shorter
time to last unformed stool (p = 0.0017) and fewer numbers of unformed stools
(p = 0.0237) than children who received placebo. The end-of-study overall
efficacy/acceptability rating of loperamide was significantly better than for
placebo (p = 0.0107). All other clinically important outcome measures related
to diarrhea relief favored loperamide. There was no significant difference in
the incidence of drug-related adverse events between treatment groups, although
total adverse events were reported more frequently (p = 0.048) by the
loperamide group (15%) compared with the placebo group (7%).
CONCLUSION:
In conclusion, this controlled study provides data demonstrating that at
recommend doses, loperamide is well tolerated and significantly shortens the
duration and severity of symptoms of acute nonspecific diarrhea in children 2
through 11 years of age.