Authors: R C Spiller N L Meyers R I Hickling
Publish Date: 2008/05/10
Volume: 53, Issue: 12, Pages: 3191-3200
Abstract
This was an exploratory study of renzapride in 168 male and female patients with nonD nonC 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 patientreported 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 182 95 CI −5 to 42 P = 0066 during weeks 1–4 and 6 95 CI −21 to 33 P = 0339 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 populationThe author’s acknowledge Parexel International for conducting this clinical study on behalf of the sponsor Alizyme Therapeutics Ltd Cambridge UK and to the clinical investigators represented by Professor R Spiller as the principle investigator for the study Statement of Interests The work reported in this paper was wholly sponsored by Alizyme Therapeutics Ltd of which Dr Meyers and Mr Hickling are employees and shareholders Professor Spiller is a consultant to Alizyme Therapeutics Ltd
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