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Completed

NCT Number: NCT01153854

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

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.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Pediatric Institute

Mexico City, 04530, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Racecadotril

Drug

oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.

Placebo groups

Drug

Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days

Primary outcomes

  1. Stool output rate

    Time frame: 2007-2009

    During the study, since the inclusion until the end of the diarrheic episode (24hs after passage of liquid or semiliquid stool) we will measure the stool output rate, reporting it at 48h and at seven day.

  2. Duration of diarrhea

    Time frame: 2007-2009

    In all included patients we will measure the duration of diarrhea, marking as a zero time the moment to sign the informed consent and the end of the diarrheic episod 24hs after the passage of the last liquid or semiliquid stool

  3. Percentage of related adverse events

    Time frame: 2007-2009

    During the duration of the study and five days after we will measure the presence of related adverse events. Any possible event ocurred after sign of consented inform will record and then classified as related or non related and as severe or notr severe adverse event

Secondary outcomes

  1. The pharmacoeconomics analysis

    Time frame: 2007-2009

    The pharmacoeconomics model consisted in a theoretical scheme that makes it possible to conduct simulations of health processes associated with medical care, use of medications, expenses for intravenous hydration and re-hospitalizations secondary to dehydration, through estimates obtained from the efficacy data available from our clinical trial as well as the costs and consequences. The model was prepared using the TreeAge Pro Healthcare v 1.2.0, 2009 software tool

Sponsors and collaborators

Lead sponsor

National Institute of Pediatrics, Mexico

Other Gov

Collaborators

  • Ferrer Laboratories

Registry information

Official study title

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

Acronym: Raceca-Mex

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 30, 2010
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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