{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T13:50:03Z","timestamp":1778939403802,"version":"3.51.4"},"reference-count":37,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T00:00:00Z","timestamp":1593043200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002975","name":"Dainippon Sumitomo Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002975","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Agonists of 5\u2010hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS\u2010C). However, only tegaserod has been approved for a very limited population in the US.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS\u2010C.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A double\u2010blind, placebo\u2010controlled, dose\u2010finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40\u00a0mg\/d, or placebo for 12\u00a0weeks. 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 \u226530% from baseline in weekly average of worst abdominal pain score, both in the same week for \u22656\/12\u00a0weeks).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The FDA composite responder rate was 13.6% (14\/103) in the placebo group, 13.6% (14\/103) in the 10\u00a0mg group, 19.2% (20\/104) in the 20\u00a0mg group and 14.9% (15\/101) in the 40\u00a0mg group, and no dose\u2010response relationship was found. A greater percentage of minesapride 40\u00a0mg\u2010treated patients than placebo\u2010treated patients met both responder requirements for \u22659\/12\u00a0weeks as the stricter composite evaluation (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.05). Furthermore, minesapride 40\u00a0mg significantly increased SBM frequency compared with placebo (adjusted <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001 at Week 12). The most common adverse event was mild diarrhoea.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Minesapride was safe and well\u2010tolerated. Although the primary endpoint was negative, minesapride 40\u00a0mg is likely to improve the stricter composite endpoint and SBM frequency.<\/jats:p><jats:p>Japan Pharmaceutical Information Center Number: Japic CTI\u2010163459.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.15907","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T10:09:12Z","timestamp":1593079752000},"page":"430-441","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9555-6057","authenticated-orcid":false,"given":"Tatsuto","family":"Hamatani","sequence":"first","affiliation":[{"name":"Sumitomo Dainippon Pharma Co., Ltd. Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2265-0349","authenticated-orcid":false,"given":"Shin","family":"Fukudo","sequence":"additional","affiliation":[{"name":"Department of Behavioral Medicine Tohoku University Graduate School of Medicine Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yosuke","family":"Nakada","sequence":"additional","affiliation":[{"name":"Sumitomo Dainippon Pharma Co., Ltd. Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Inada","sequence":"additional","affiliation":[{"name":"Sumitomo Dainippon Pharma Co., Ltd. Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyoyasu","family":"Kazumori","sequence":"additional","affiliation":[{"name":"Sumitomo Dainippon Pharma Co., Ltd. Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroto","family":"Miwa","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Department of Internal Medicine Hyogo College of Medicine Nishinomiya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,6,25]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_8_3_1","first-page":"967","volume-title":"Rome IV: Functional Gastrointestinal Disorders; Disorders of Gut\u2010Brain Interaction","author":"Mearin F","year":"2016"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/gast.2000.16484"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0269-2813.2004.01807.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2015-311240"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-019-0985-1"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2006.11.002"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2019.07.007"},{"key":"e_1_2_8_10_1","unstructured":"Highlights of prescribing information (Zelnorm).https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021200Orig1s015lbl.pdf. 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