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Design of a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of prucalopride in pediatric patients with functional constipation

BACKGROUND: A previous phase 3 trial of prucalopride in pediatric patients (6 months–18 years old) with functional constipation (FC) demonstrated no efficacy versus placebo. We designed an additional phase 3 trial to further assess the efficacy, long-term safety and tolerability of prucalopride in c...

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Detalles Bibliográficos
Autores principales: Cuffari, Carmen, Spalding, William, Achenbach, Heinrich, Thakur, Manoj, Gabriel, André
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192401/
https://www.ncbi.nlm.nih.gov/pubmed/37215389
http://dx.doi.org/10.1016/j.conctc.2023.101144