Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide.
Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a
controversial subject. Since ten years ago, Racecadotrilo´s safety and efficacy had been
proved. However, a pharmacoeconomics analysis on this therapeutics has not been published
yet.
Objective: Evaluate the efficacy, safety, tolerability and costs associated with Racecadotril
administration in comparison to a placebo in infants up to 24 months of age with AD in a
hospital (mildly or moderately dehydrated) and ambulatory (no dehydrated) settings at the
National Institute of Pediatrics in Mexico.
Material and Methods: Randomized, double-blind, placebo controlled, clinical trial (RDBCCT)
with pharmacoeconomics analysis (cost minimization) to realize in 454 infants with AD (270
hospitalized and 184 outpatients), 1 to 24 months of age who concomitantly will receive ORT
and Racecadotril (1.5mg./Kg./t.i.d. doe 5 days) (ORT-Rac Group) or placebo (ORT-Placebo
Group). The clinical outcomes in the hospitalized infants to measure will be a) Stool output
rate at 48hs. and at the end of the study; b) duration of diarrhea; c) percentage of
intravenous (IV) needs and d) percentage of adverse events. The outcome variables in
outpatient infants to measure will be a) total liquid and semi-liquid bowel movements during
the study; b) duration of diarrhea and c) percentage of adverse events. The pharmacoeconomics
analysis will involve a cost minimization analysis (CMA). Results will be analyzed through bi
and multivariate analysis using STATA 11.0 for Mac, considering a p value < 0.05 as
significant. The pharmacoeconomics model will made through decisions trees using TreAge Pro
Healthcare v 1.2.0, 2009.