Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study.
Affiliation
Alimentary Pharmabiotic Centre, University College Cork, Cork, Ireland. e.quigley@ucc.ieIssue Date
2009-02-01MeSH
Administration, OralAdolescent
Adult
Aged
Aged, 80 and over
Benzofurans
Chronic Disease
Constipation
Defecation
Double-Blind Method
Female
Gastrointestinal Transit
Humans
Male
Middle Aged
Patient Satisfaction
Placebos
Quality of Life
Questionnaires
Serotonin Receptor Agonists
Treatment Outcome
Young Adult
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Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study. 2009, 29 (3):315-28 Aliment. Pharmacol. Ther.Journal
Alimentary pharmacology & therapeuticsDOI
10.1111/j.1365-2036.2008.03884.xPubMed ID
19035970Abstract
Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT(4) receptor agonist, prucalopride, in patients with chronic constipation [
Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with >or=3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability.
Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (>or=3 SCBMs/week) or an increase of >or=1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events.
Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.
Item Type
ArticleLanguage
enISSN
1365-2036ae974a485f413a2113503eed53cd6c53
10.1111/j.1365-2036.2008.03884.x
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