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

Diarrhea Clinical Trial

— Raceca-Mex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153854
• Other study ID #: INP14/2005-Raceca-001
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2010
• Last updated: June 29, 2010
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: National Institute of Pediatrics, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: December 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Mexico	National Pediatric Institute	Mexico city

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Pediatrics, Mexico	Ferrer Laboratories

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Cézard JP, Duhamel JF, Meyer M, Pharaon I, Bellaiche M, Maurage C, Ginies JL, Vaillant JM, Girardet JP, Lamireau T, Poujol A, Morali A, Sarles J, Olives JP, Whately-Smith C, Audrain S, Lecomte JM. Efficacy and tolerability of racecadotril in acute diarrhea in children. Gastroenterology. 2001 Mar;120(4):799-805. — View Citation

Cezard JP, Salazar-Lindo E. Racecadotril in acute diarrhea. Indian Pediatr. 2005 May;42(5):502-3; author reply 503. — View Citation

Cojocaru B, Bocquet N, Timsit S, Wille C, Boursiquot C, Marcombes F, Garel D, Sannier N, Chéron G. [Effect of racecadotril in the management of acute diarrhea in infants and children]. Arch Pediatr. 2002 Aug;9(8):774-9. French. — View Citation

Rao SG. Racecadotril (acetorphan) in the treatment of acute watery diarrhoea in children. J Indian Med Assoc. 2002 Aug;100(8):530. — View Citation

Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. Racecadotril in the treatment of acute watery diarrhea in children. N Engl J Med. 2000 Aug 17;343(7):463-7. — View Citation

Szajewska H, Ruszczynski M, Chmielewska A, Wieczorek J. Systematic review: racecadotril in the treatment of acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Sep 15;26(6):807-13. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool output rate	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.	2007-2009	No
Primary	Duration of diarrhea	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	2007-2009	No
Primary	Percentage of related adverse events	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	2007-2009	Yes
Secondary	The pharmacoeconomics analysis	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	2007-2009	No