Clinical trial: renzapride therapy for constipation‐predominant irritable bowel syndrome – multicentre, randomized, placebo‐controlled, double‐blind study in primary healthcare setting

@article{George2008ClinicalTR,
  title={Clinical trial: renzapride therapy for constipation‐predominant irritable bowel syndrome – multicentre, randomized, placebo‐controlled, double‐blind study in primary healthcare setting},
  author={Amrutha Mary George and Nicholas L Meyers and Roger I. Hickling},
  journal={Alimentary Pharmacology \& Therapeutics},
  year={2008},
  volume={27}
}
Background  Relatively few pharmacological treatment options are available for treating patients with irritable bowel syndrome. New and effective medicines are urgently required. 
On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study
TLDR
A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief.
Current management strategies and therapeutic targets in chronic constipation
  • A. Emmanuel
  • Medicine
    Therapeutic advances in gastroenterology
  • 2011
TLDR
Newer prokinetic agents, targeting peristalsis, intestinal secretion and the colonic flora, have been developed for laxative refractory constipation, and the relative indications for each of them are focused on.
Renzapride: a new drug for the treatment of constipation in the irritable bowel syndrome
TLDR
Renzapride is a mixed 5-hydroxytryptamine type 4 (5-HT4) agonist and 5-HT3 receptor antagonist that has a stimulatory effect on gastrointestinal motility and transit, as established by in vivo and in vitro studies.
Treatment of irritable bowel syndrome in women.
TLDR
Because pathophysiologic differences exist between men and women, so does the efficacy of treatment options, and these differences could further explain gender-related differences in disease prevalence and treatment response.
Pharmacological management of constipation
Abstract  The approach of this review is to give a pragmatic approach to using laxatives, based on a combination of what is known about mechanism of action and the available literature on evidence.
Efficacy and tolerability of renzapride in irritable bowel syndrome: a meta-analysis of randomized, controlled clinical trials including 2528 patients
TLDR
Renzapride is not superior to placebo in relieving IBS symptoms and causes significant incidences of diarrhea and drop-outs due to adverse effects in treated patients vs. placebo, suggesting this medicine might be a cost burden to patients without providing good effectiveness.
Meta‐analysis: factors affecting placebo response rate in the irritable bowel syndrome
Aliment Pharmacol Ther 2010; 32: 144–158
Current and Emerging Pharmacotherapeutic Options for Irritable Bowel Syndrome
TLDR
This review will focus on randomized controlled trials with a general uniformity in study design, a rigorous patient selection and appropriate treatment durations, which may prove promising in treating patients with irritable bowel syndrome.
Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders
TLDR
The nonselective 5‐HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs) and the use of these drugs in clinical practice is still under investigation.
...
1
2
3
4
...

References

SHOWING 1-10 OF 24 REFERENCES
Pilot study of the efficacy of renzapride on gastrointestinal motility and symptoms in patients with constipation‐predominant irritable bowel syndrome
TLDR
To investigate the efficacy and safety of renzapride in patients with constipation‐predominant irritable bowel syndrome, a potent 5‐hydroxytryptamine type‐4 receptor full agonist and 5‐ Hydroxytryptamines type‐3 receptor antagonist are studied.
The placebo effect in irritable bowel syndrome trials: a meta‐analysis 1
  • S. M. Patel, W. Stason, +9 authors A. Lembo
  • Medicine
    Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society
  • 2005
TLDR
Despite the apparent high placebo response rate in randomized placebo‐controlled trials of patients with irritable bowel syndrome (IBS), little is known about the variability and predictors of this response.
Tegaserod, a 5‐HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation
To investigate the efficacy and safety of tegaserod, a novel 5‐HT4 receptor partial agonist, in a randomized, double‐blind, placebo‐controlled, 12‐week treatment, multicentre study.
Efficacy of alosetron in irritable bowel syndrome: a meta‐analysis of randomized controlled trials
TLDR
The present analysis shows that alosetron 1 mg b.i.d. positively impacts global symptoms, and pain and discomfort in non‐constipated IBS female patients.
Effect of renzapride on transit in constipation-predominant irritable bowel syndrome.
  • M. Camilleri, S. Mckinzie, +5 authors A. Zinsmeister
  • Medicine
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
  • 2004
TLDR
Renzapride causes clinically significant dose-related acceleration of CT, particularly ascending colonic emptying; this acceleration of transit is associated with improvement of bowel function in female C-IBS patients.
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).
Irritable Bowel Syndrome
TLDR
The physician must warn his/her patients that immediate results are rarely obtained and that a prolonged clinical follow up may be necessary.
AGA technical review on irritable bowel syndrome.
TLDR
Psychosocial factors, although not part of IBS per se, have an important role in modulating the illness experience and its clinical outcome.
Problems and challenges in the design of irritable bowel syndrome clinical trials: experience from published trials.
  • R. Spiller
  • Medicine
    The American journal of medicine
  • 1999
TLDR
The most important finding has been that the median placebo response was 47%, which is approximately three times the size of the difference between placebo and drug response, median 16% (range, -17-64%).
Defining the predictors of the placebo response in irritable bowel syndrome.
  • M. Pitz, M. Cheang, C. Bernstein
  • Medicine
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
  • 2005
TLDR
In IBS studies, higher placebo response rates correlated with frequency of the intervention and with overall treatment effect of the active agent being studied, suggesting it may be possible to minimize placebo response by less frequent dosing.
...
1
2
3
...