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

@article{Quigley2009ClinicalTT,
  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},
  author={Eamonn M. M. Quigley and Lieve Vandeplassche and Ren{\'e} Kerstens and Jannie Ausma},
  journal={Alimentary Pharmacology \& Therapeutics},
  year={2009},
  volume={29}
}
Background  Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL). 
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A randomized, double‐blind, placebo‐controlled trial to evaluate the efficacy, safety, and tolerability of long‐term treatment with prucalopride
Randomized trials have confirmed the efficacy of prucalopride for the treatment of chronic constipation up to 12 weeks. This study aimed to assess the efficacy of prucalopride over a 24‐week period…
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Aliment Pharmacol Ther 2010; 32: 1102–1112
Prucalopride in the treatment of chronic constipation in patients from the Asia-Pacific region: a randomized, double-blind, placebo-controlled study
  • M. Ke, D. Zou, +5 authors Hj. Kim
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  • 2012
TLDR
This study evaluated efficacy and safety of the 2 mg dose of prucalopride compared to placebo in patients with chronic constipation from the Asia‐Pacific region.
Association between health‐related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride
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Background  The Patient Assessment of Constipation–Quality of Life (PAC‐QOL) is a self‐reported questionnaire measuring health‐related quality of life (HRQL) of constipated patients and was used as…
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Aliment Pharmacol Ther 2010; 32: 1113–1123
Sa1390 Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized Controlled Clinical Trials
TLDR
Prucalopride stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation in adults and the relative efficacy by gender has not been evaluated.
Randomised clinical trial: the efficacy of prucalopride in patients with chronic intestinal pseudo-obstruction - a double-blind, placebo-controlled, cross-over, multiple n = 1 study
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Diagnosis and treatment of chronic constipation – a European perspective
  • J. Tack, S. Müller-lissner, +5 authors M. Fried
  • Medicine
    Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society
  • 2011
TLDR
Management guidelines and recommendations are limited and are not sufficiently current to include treatments that became available more recently, such as prokinetic agents in Europe.
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References

SHOWING 1-10 OF 55 REFERENCES
The burden of constipation on quality of life: results of a multinational survey
TLDR
This study highlights the need to understand more fully the role that sanitation plays in the quality of life of individuals in different cultural or national settings.
Chronic constipation: a survey of the patient perspective
Background  Constipation is a common, often chronic, gastrointestinal motility disorder characterized by such symptoms as straining, hard stool, and infrequent defecation. Published literature is…
A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation
TLDR
Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment and produced greater satisfaction, work productivity, and improved quality of life than placebo (p<0.05).
Prucalopride Is Effective in Patients with Severe Chronic Constipation in Whom Laxatives Fail to Provide Adequate Relief
TLDR
Once-daily prucalopride 4 mg for 4 weeks is effective and well tolerated in patients with severe CC, and improves whole gut transit, reducing straining, softening stools and reducing time to first bowel movement.
Effect of tegaserod on work and daily activity in irritable bowel syndrome with constipation
TLDR
Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation and is being investigated for use in combination with chemotherapy for bowel problems.
Effect of tegaserod in chronic constipation: a randomized, double-blind, controlled trial.
  • J. Johanson, A. Wald, +6 authors B. Nault
  • Medicine
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
  • 2004
TLDR
Tegaserod treatment produced significant improvements in chronic constipation symptoms and was also safe and well tolerated; headache and nasopharyngitis, the most frequent adverse events, were more common in the placebo group than in either tegaserod group.
A placebo-controlled trial of prucalopride for severe chronic constipation.
TLDR
Over 12 weeks, prucalopride significantly improved bowel function and reduced the severity of symptoms in patients with severe chronic constipation.
Efficacy and Safety of Traditional Medical Therapies for Chronic Constipation: Systematic Review
TLDR
There is good evidence to support the use of PEG, tegaserod, lactulose, and psyllium and recommendations were made regarding their use following the United States Preventive Services Task Force guidelines.
Efficacy and Tolerability of Prucalopride in Patients with Constipation due to Spinal Cord Injury
TLDR
This pilot study indicates that prucalopride can play an important role in the management of patients with CC due to SCI, and a clear dose response for treatment efficacy is shown.
Effects of prucalopride on colonic transit, anorectal function and bowel habits in patients with chronic constipation
TLDR
Prucalopride is a highly selective, specific, serotonin4 receptor agonist with enterokinetic properties that has the potential to normalize bowel function in chronic constipation.
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