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Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials
Author(s) -
Koppen I. J. N.,
Saps M.,
Lavigne J. V.,
Nurko S.,
Taminiau J. A. J. M.,
Di Lorenzo C.,
Benninga M. A.
Publication year - 2018
Publication title -
neurogastroenterology and motility
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.489
H-Index - 105
eISSN - 1365-2982
pISSN - 1350-1925
DOI - 10.1111/nmo.13294
Subject(s) - medicine , clinical trial , functional constipation , constipation , placebo , pediatrics , randomized controlled trial , alternative medicine , population , intensive care medicine , physical therapy , family medicine , pathology , environmental health
Background Evidence for the efficacy of commonly used drugs in the treatment of childhood functional constipation ( FC ) is scarce, studies are often of low quality and study designs are heterogeneous. Thus, recommendations for the design of clinical trials in childhood FC are needed. Purpose Members of the Rome Foundation and a member of the Pediatric Committee of the European Medicines Agency formed a committee to create recommendations for the design of clinical trials in children with FC . Key Recommendations This committee recommends conducting randomized, double‐blind, placebo‐controlled, parallel‐group clinical trials to assess the efficacy of new drugs for the treatment of childhood FC . Pediatric study participants should be included based on fulfilling the Rome IV criteria for FC . A treatment free run‐in period for baseline assessment is recommended. The trial duration should be at least 8 weeks. Treatment success is defined as no longer meeting the Rome IV criteria for FC . Stool consistency should be reported based on the Bristol Stool Scale. Endpoints of drug efficacy need to be tailored to the developmental age of the patient population.