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

This study has been completed.
Sponsor:
Collaborator:
Ferrer Laboratories
Information provided by:
National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier:
NCT01153854
First received: June 28, 2010
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Diarrhea
Drug: Racecadotril
Drug: Placebo groups
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Cost-effectiveness Analysis of Impact of Racecadotril as an Adjunct in the Treatment of Acute Diarrhea in Mexican Children

Resource links provided by NLM:


Further study details as provided by National Institute of Pediatrics, Mexico:

Primary Outcome Measures:
  • Stool output rate [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
    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.

  • Duration of diarrhea [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
    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

  • Percentage of related adverse events [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • The pharmacoeconomics analysis [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
    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


Enrollment: 454
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORS-Raceca In hospital Group
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.
Drug: Racecadotril
oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.
Placebo Comparator: ORS-Placebo in hospital group
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.
Drug: Placebo groups
Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days
Placebo Comparator: ORS-Placebo ambulatory group
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.
Drug: Placebo groups
Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days
Experimental: ORS-Raceca ambulatory group
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.
Drug: Racecadotril
oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153854

Locations
Mexico
National Pediatric Institute
Mexico city, Mexico, 04530
Sponsors and Collaborators
National Institute of Pediatrics, Mexico
Ferrer Laboratories
Investigators
Principal Investigator: Pedro Gutierrez-Castrellon, MD, MSc, DSc National Pediatric Institute
  More Information

Publications:
Responsible Party: Pedro Gutierrez-Castrellon MD, MSc, DSc, National Pediatric Institute
ClinicalTrials.gov Identifier: NCT01153854     History of Changes
Other Study ID Numbers: INP14/2005-Raceca-001
Study First Received: June 28, 2010
Last Updated: June 29, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by National Institute of Pediatrics, Mexico:
acute diarrhea
Acute diarrhea (three or more watery or semi-watery bowel movements for at least one day lasting no more than 5 days before being admitted)

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Racecadotril
Thiorphan
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014