Journal article
Randomised clinical trial: The efficacy of prucalopride in patients with chronic intestinal pseudo-obstruction - A double-blind, placebo-controlled, cross-over, multiple n = 1 study
AV Emmanuel, MA Kamm, AJ Roy, R Kerstens, L Vandeplassche
Alimentary Pharmacology and Therapeutics | Published : 2012
Abstract
Background Chronic intestinal pseudo-obstruction is a disabling condition for which there are no established drug therapies. The condition is caused by a diverse range of intestinal myopathies and neuropathies. Aim To assess the therapeutic efficacy of prucalopride, a selective high-affinity 5-HT 4 receptor agonist, we employed a multiple n = 1 study design. Each patient acted as his/her own control, each day counting as one treatment episode, allowing comparison of 168 days on each of active drug and placebo. Methods Double-blind, randomised, placebo-controlled, cross-over trial of four 12-week treatment periods, with 2-4 mg prucalopride or placebo daily. In each of the first and second 6 m..
View full abstractGrants
Funding Acknowledgements
Declaration of personal interests: Michael Kamm has served as a speaker, a consultant and an advisory board member for Shire-Movetis, and has received previous research funding from Janssen. Anton Emmanuel has served as a speaker and an advisory board member for Shire, Takeda, GSK, Mundipharma, Coloplast. Rene Kerstens and Lieve Vandeplassche are employees of Shire-Movetis. The writing and preparation of this article was performed by the authors (Michael A Kamm and Anton V Emmanuel) without payment, but preparation was undertaken with the assistance of Shire-Movetis. Declaration of funding interests: This study was funded in part by Janssen. Technical support in the formatting, preparation of relevant submission details and materials, and submission of this paper was performed by Kerri Bridgwater and funded by Shire-Movetis.