Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico (Raceca-Mex)

National Institute of Pediatrics, Mexico

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Drug: Placebo groups; Drug: Racecadotril

Study type: Interventional

Funder types: Other

Identifiers

NCT01153854

INP14/2005-Raceca-001

Details and patient eligibility

About

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.

Enrollment: 454 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children ≥ 1 month of age and ≤ 24 months of age
• Acute diarrhea (defined as three or more watery or semi-watery bowel movements for at least one day lasting no more than 5 days before being admitted)
• For in hospital group: mild or moderate dehydration
• Signed informed consent letter

Exclusion criteria

• previous use of oral antibiotics for more than 48 hours (during the two weeks before the trial
• previous use of anti-diarrheal medication (e.g.: bismuth subsalicylate, adsorbents, Loperamide, combinations)
• chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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454 participants in 4 patient groups, including a placebo group

ORS-Raceca In hospital Group

Experimental group

Description:

This group included 135 dehydrated patients which need an oral rehydration therapy in hospital and were assigned to received oral rehydration solution and racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.

Treatment:

Drug: Racecadotril

ORS-Placebo in hospital group

Placebo Comparator group

Description:

This group included 135 dehydrated patients which need an oral rehydration therapy in hospital and were assigned to received oral rehydration solution and placebo in double blind assigned.

Treatment:

Drug: Placebo groups

ORS-Placebo ambulatory group

Placebo Comparator group

Description:

This group included 92 non dehydrated patients which were assigned to received oral rehydration solution and placebo in double blind assigned and ambulatory (in home) bases.

Treatment:

Drug: Placebo groups

ORS-Raceca ambulatory group

Experimental group

Description:

This group included 92 non dehydrated patients which were assigned to received oral rehydration solution and racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned and ambulatory (in home) bases.

Treatment:

Drug: Racecadotril