Identification of patients with non-d, non-C irritable bowel syndrome and treatment with renzapride: an exploratory, multicenter, randomized, double-blind, placebo-controlled clinical trial.
This was an exploratory study of renzapride in 168 male and female patients with non-D, non-C irritable bowel syndrome (IBS). Patients were randomized to placebo or renzapride (1, 2, or 4 mg/day) for 8 weeks. The primary efficacy variable was patient-reported satisfactory relief of IBS symptoms. Secondary variables included relief of abdominal pain/discomfort. The proportion of patients reporting satisfactory relief of their IBS symptoms for at least 50% of the time did not differ significantly from those on placebo. However, post hoc analysis in women showed differences in responder rate on renzapride versus placebo of 18.2% (95% CI -5% to 42%; P = 0.066) during weeks 1-4 and 6% (95% CI -21% to 33%; P = 0.339) during weeks 5-8. Renzapride was well tolerated and most adverse events were mild to moderate in intensity. Further studies are warranted to determine whether renzapride is beneficial in this patient population.
Spiller
R C
RC
Division of Gastroenterology, University Hospital, Nottingham, UK.
Meyers
N L
NL
Hickling
R I
RI
D000328:Adult; D001549:Benzamides / Q000627:therapeutic use*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000627:therapeutic use*; D003672:Defecation / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000145:classification* / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D058831:Serotonin 5-HT3 Receptor Antagonists; D058828:Serotonin 5-HT4 Receptor Agonists; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome
D001549:Benzamides; D019086:Bridged Bicyclo Compounds, Heterocyclic; D058831:Serotonin 5-HT3 Receptor Antagonists; D058828:Serotonin 5-HT4 Receptor Agonists; D012702:Serotonin Antagonists; C053006:renzapride