A placebo-controlled trial of prucalopride for severe chronic constipation

Michael Camilleri, René Kerstens, An Rykx, Lieve Vandeplassche

Research output: Contribution to journalArticle

391 Citations (Scopus)

Abstract

Background: In this 12-week trial, we aimed to determine the efficacy of prucalopride, a selective, high-affinity 5-hydroxytryptamine4 receptor agonist, in patients with severe chronic constipation. Methods: In our multicenter, randomized, placebo-controlled, parallel-group, phase 3 trial, patients with severe chronic constipation (≤2 spontaneous, complete bowel movements per week) received placebo or 2 or 4 mg of prucalopride, once daily, for 12 weeks. The primary efficacy end point was the proportion of patients having three or more spontaneous, complete bowel movements per week, averaged over 12 weeks. Secondary efficacy end points were derived from daily diaries and validated questionnaires completed by patients. Adverse events, clinical laboratory values, and cardiovascular effects were monitored. Results: Efficacy was analyzed in 620 patients. The proportion of patients with three or more spontaneous, complete bowel movements per week was 30.9% of those receiving 2 mg of prucalopride and 28.4% of those receiving 4 mg of prucalopride, as compared with 12.0% in the placebo group (P

Original languageEnglish (US)
Pages (from-to)2344-2354
Number of pages11
JournalNew England Journal of Medicine
Volume358
Issue number22
DOIs
StatePublished - May 29 2008

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prucalopride
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Placebos

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A placebo-controlled trial of prucalopride for severe chronic constipation. / Camilleri, Michael; Kerstens, René; Rykx, An; Vandeplassche, Lieve.

In: New England Journal of Medicine, Vol. 358, No. 22, 29.05.2008, p. 2344-2354.

Research output: Contribution to journalArticle

Camilleri, Michael ; Kerstens, René ; Rykx, An ; Vandeplassche, Lieve. / A placebo-controlled trial of prucalopride for severe chronic constipation. In: New England Journal of Medicine. 2008 ; Vol. 358, No. 22. pp. 2344-2354.
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