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dc.contributor.authorQuigley, E M M
dc.contributor.authorVandeplassche, L
dc.contributor.authorKerstens, R
dc.contributor.authorAusma, J
dc.date.accessioned2012-01-10T12:51:06Z
dc.date.available2012-01-10T12:51:06Z
dc.date.issued2009-02-01
dc.identifier.citationClinical 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.en
dc.identifier.issn1365-2036
dc.identifier.pmid19035970
dc.identifier.doi10.1111/j.1365-2036.2008.03884.x
dc.identifier.urihttp://hdl.handle.net/10147/201249
dc.descriptionBACKGROUND: Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL). AIM: 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 [<or=2 spontaneous complete bowel movements (SCBMs)/week]. METHODS: 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. RESULTS: 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. CONCLUSION: Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.en
dc.description.abstractChronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).
dc.description.abstractA 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 [
dc.description.abstractPlacebo, 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.
dc.description.abstractAmong 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.
dc.description.abstractOver 12 weeks, prucalopride was effective and well tolerated in chronic constipation.
dc.language.isoenen
dc.subject.meshAdministration, Oral
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshBenzofurans
dc.subject.meshChronic Disease
dc.subject.meshConstipation
dc.subject.meshDefecation
dc.subject.meshDouble-Blind Method
dc.subject.meshFemale
dc.subject.meshGastrointestinal Transit
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshPatient Satisfaction
dc.subject.meshPlacebos
dc.subject.meshQuality of Life
dc.subject.meshQuestionnaires
dc.subject.meshSerotonin Receptor Agonists
dc.subject.meshTreatment Outcome
dc.subject.meshYoung Adult
dc.titleClinical 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.en
dc.typeArticleen
dc.contributor.departmentAlimentary Pharmabiotic Centre, University College Cork, Cork, Ireland. e.quigley@ucc.ieen
dc.identifier.journalAlimentary pharmacology & therapeuticsen
dc.description.provinceMunster
html.description.abstractChronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).
html.description.abstractA 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 [<or=2 spontaneous complete bowel movements (SCBMs)/week].
html.description.abstractPlacebo, 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.
html.description.abstractAmong 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.
html.description.abstractOver 12 weeks, prucalopride was effective and well tolerated in chronic constipation.


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