Randomized, double blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of long-term treatment (24 weeks) with prucalopride in patients with chronic constipation
Project Objectives
Prucalopride (Resolor®) is a new drug for the treatment of chronic constipation in women who do not gain adequate relief from laxatives. It was approved by the European Commission for the treatment of constipation in women in October 2009.
Prucalopride is not yet approved for the treatment of constipation in male patients and remains an experimental drug for this gender. Prucalopride, in doses of 2 mg and 4 mg per day, has been shown to be effective in increasing the frequency of evacuation and improving associated symptoms and quality of life in patients with chronic constipation.
It has been shown to be safe and well tolerated in healthy volunteers and in patients. Specific studies have been performed in elderly patients (i.e. 65 years old or older) with chronic constipation. These studies have confirmed the efficacy of prucalopride in this group of patients. Furthermore, these studies have shown that in elderly patients a dose of 1 mg per day is as effective as 2 mg per day.
It is therefore recommended that elderly patients with chronic constipation begin treatment with prucalopride with a dose of 1 mg per day as stated in the current PIL for prucalopride. The objective of this clinical trial is to study the long-term efficacy and safety of prucalopride in a large number of patients of 18 years or more with chronic constipation.
Half of the patients receive placebo (a tablet that has exactly the same appearance as one tablet of prucalopride but no active ingredients) and half of the patients receive 2 mg prucalopride daily. Patients aged less than 65 years start with the placebo or 1 mg prucalopride daily.
Start/End Date
2011 - 2012
Principal Investigator
Prof. Michele Cicala
Host Institution
Campus Bio-Medico University of Rome
Other Institutions involved
Multicenter clinical trial protocol, conducted in 59 centers across Europe (Trial N°: M0001-C401).
Sourceof funding
The clinical trial protocol was sponsored by SHIRE-MOVETIS