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.

Hdl Handle:
http://hdl.handle.net/10147/201249
Title:
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.
Authors:
Quigley, E M M; Vandeplassche, L; Kerstens, R; Ausma, J
Affiliation:
Alimentary Pharmabiotic Centre, University College Cork, Cork, Ireland. e.quigley@ucc.ie
Citation:
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 & therapeutics
Issue Date:
1-Feb-2009
URI:
http://hdl.handle.net/10147/201249
DOI:
10.1111/j.1365-2036.2008.03884.x
PubMed ID:
19035970
Abstract:
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 [<or=2 spontaneous complete bowel movements (SCBMs)/week].; 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:
Article
Language:
en
Description:
BACKGROUND: 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.
MeSH:
Administration, Oral; Adolescent; 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
ISSN:
1365-2036

Full metadata record

DC FieldValue Language
dc.contributor.authorQuigley, E M Men
dc.contributor.authorVandeplassche, Len
dc.contributor.authorKerstens, Ren
dc.contributor.authorAusma, Jen
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 [<or=2 spontaneous complete bowel movements (SCBMs)/week].-
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-

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