NCT01153854

Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico

Efficacy, Safety and Cost-effectiveness Analysis of Impact of Racecadotril as an Adjunct in the Treatment of Acute Diarrhea in Mexican Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: National Institute of Pediatrics, Mexico · Other Government
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Racecadotril	oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.
DRUG	Placebo groups	Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2009-12-01
• First posted: 2010-06-30
• Last updated: 2010-06-30

Locations

1 site across 1 country: Mexico