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Summary   Background  Agonists of 5‐hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS‐C). However, only tegaserod has been approved for a very limited population in the US.    Aim  To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS‐C.    Methods  A double‐blind, placebo‐controlled, dose‐finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was 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).    Results  The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose‐response relationship was found. A greater percentage of minesapride 40 mg‐treated patients than placebo‐treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation ( P  < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted  P  < 0.001 at Week 12). The most common adverse event was mild diarrhoea.    Conclusions  Minesapride was safe and well‐tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency.  Japan Pharmaceutical Information Center Number: Japic CTI‐163459.

Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation