A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy, quality of life, safety and tolerability of long-term (24 weeks) treatment with prucalopride in subjects with chronic constipation
Project objectivesPrucalopride (Resolor®) is a new medication for the treatment of chronic constipation in women who do not receive adequate relief from laxatives. Prucalopride was approved by the European Commission (October 2009) for the treatment of constipation in women. Prucalopride has not yet been approved for the treatment of constipation in men and is an investigational drug for this population. Prucalopride, in doses of 2 mg and 4 mg daily, has been shown to be effective in increasing bowel movement frequency 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 patients. Specific studies have been conducted in elderly patients (i.e., patients aged 65 years or older) with chronic constipation. These studies have confirmed the efficacy of prucalopride in this patient group. Furthermore, these studies have shown that in elderly patients, a dose of 1 mg daily is as effective as a dose of 2 mg daily. The current labeling for prucalopride recommends that elderly patients with chronic constipation begin treatment with prucalopride at a dose of 1 mg daily. The objective of this clinical trial is to study the long-term efficacy and safety of prucalopride in a large cohort of patients aged 18 years and older with chronic constipation. Half of the patients receive a placebo (a tablet that looks exactly like a prucalopride tablet but without the active ingredients) and half receive 2 mg of prucalopride daily. Patients aged 65 years and older begin with a placebo or 1 mg of prucalopride daily. |
Start and end date |
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2011 - 2012 |
Project Manager |
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Prof. Michele Cicala - Director of the Gastroenterology Unit, Associate Professor of Gastroenterology |
Coordinating institution of the project |
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Università Campus Bio-Medico di Roma |
Other Institutions involved |
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Multicenter clinical trial protocol, conducted in 59 centers across Europe (Trial number: M0001-C401) |
Funding source(s). |
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The experimental clinical protocol was sponsored by SHIRE-MOVETIS |
