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Prucalopride belongs to a novel class of 5-hydroxytryptamine-4 receptor agonists, and has been evaluated extensively for the treatment of chronic constipation. Prucalopride has a stimulatory effect on gastrointestinal motility and transit, as established by in vivo and in vitro studies in animals and humans. Its therapeutic efficacy, tolerability and safety have been evaluated in Phase II and Phase III studies in chronic constipation. The cardiovascular safety profile of the drug was studied in vitro and in vivo in animal studies, in clinical studies in chronic constipation patients, as well as in specific additional clinical cardiovascular studies. Phase II studies identified a dose-dependent effect of prucalopride on bowel pattern and associated symptoms in chronic constipation. The Phase III studies mainly recruited patients with insufficient response to laxatives, and showed consistent efficacy and excellent tolerability for prucalopride.
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Jan Tack (2009) studied this question.
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