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