Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation
Alimentary Pharmacology and Therapeutics Jul 01, 2020
Hamatani T, Fukudo S, Nakada Y, et al. - The efficacy and safety of minesapride was investigated in patients with Rome IV defined irritable bowel syndrome with predominant constipation (IBS‐C). Researchers conducted a double‐blind, placebo‐controlled, dose‐finding study, randomizing 411 patients to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The placebo group had the FDA composite responder rate of 13.6% (14/103), the 10 mg group had 13.6% (14/103), the 20 mg group had 19.2% (20/104) and the 40 mg group had 14.9% (15/101); there was no dose‐response relationship. Minesapride was identified as safe among these patients; the patients well‐tolerated minesapride. Although the primary endpoint of Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥ 30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥ 6/12 weeks) was negative, minesapride 40 mg seems to have tendency to improve the stricter composite endpoint and spontaneous bowel movement frequency.
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