Original ResearchFull Report: Clinical—Alimentary TractPrucalopride Is No More Effective Than Placebo for Children With Functional Constipation
Section snippets
Study Design
A multicenter, randomized phase 3 trial was conducted from April 2011 to March 2013 at 33 centers in Europe (ClinicalTrials.gov: NCT01330381). The trial comprised an 8-week double-blind, placebo-controlled period and a 16-week, open-label, active-controlled period (Figure 1).
The study was conducted in accordance with the International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, and applicable local ethical and legal requirements. The
Enrollment
Of the 304 screened patients, 89 were excluded before randomization (Figure 2). Therefore, 215 patients were randomized, 107 to the prucalopride group and 108 to the placebo group. Two patients withdrew consent before investigational product dosing and, as a result, the safety population comprised 213 children (prucalopride: 106; placebo: 107). The per-protocol set excluded 12 patients who stopped treatment with the investigational product before day 37, and 43 who had a protocol violation that
Discussion
This multicenter, placebo-controlled, double-blind trial used a carefully chosen primary end point to evaluate the efficacy of prucalopride in children fulfilling the Rome III criteria for functional constipation. In contrast to adults with constipation, the majority of children have infrequent defecation accompanied by FI as a result of rectal fecal impaction; therefore, effective treatment should lead not only to an increase in defecation frequency but also to a decrease in FI. For this
Acknowledgments
The authors would like to thank the following investigators who, together with their site personnel, enrolled patients into the study. Belgium: G. Veereman-Wauter, I. Paquot, M. Scaillon, E. Sokal; France: F. Gottrand; Germany: S. Koletsko, A. Krahl; Hungary: J. Biro, F. Fekete, L. Karsza, E. Stunya, E. Szakos, C. Szekely, E. Tomsits, G. Toth; Italy: A. Staiano; Netherlands: M. Groeneweg, O. Norbruis, N. van den Berg; Poland: E. Happyn, B. Iwanczak, J. Kierkus, H. Szajewska; UK: N., Croft, R.,
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Conflicts of interest These authors disclose the following: Alexandra Green and Amy Levine are employees of Shire. Rene Kerstens, Jannie Ausma, and Magnus Ruth are former employees of Shire-Movetis. Marc A. Benninga is a consultant for AstraZeneca, Danone, Shire, Sucampo, and Zeria. The remaining authors disclose no conflicts.
Funding This study was sponsored by Shire Development LLC.