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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Bibliographic Details
Main Authors: Carmen Cuffari, William Spalding, Heinrich Achenbach, Manoj Thakur, André Gabriel
Format: Article
Language:English
Published: Elsevier 2023-06-01
Series:Contemporary Clinical Trials Communications
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S245186542300090X