{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:25:21Z","timestamp":1786980321958,"version":"build-2736575974"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2017,8,24]],"date-time":"2017-08-24T00:00:00Z","timestamp":1503532800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2017,8,24]],"date-time":"2017-08-24T00:00:00Z","timestamp":1503532800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100014421","name":"EA Pharma Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014421","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Gastroenterol"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Elobixibat is an oral treatment candidate for chronic constipation with a novel mechanism of action via inhibition of the ileal bile acid transporter. We performed this randomized, double-blind, placebo-controlled, dose-finding phase IIb study in Japanese patients with chronic constipation to determine the optimal clinical dose of elobixibat.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Japanese patients with chronic constipation were randomized to receive elobixibat (5, 10, or 15\u00a0mg) or placebo once daily for 2\u00a0weeks. The primary efficacy endpoint was the change from baseline in frequency of spontaneous bowel movements at Week\u00a01 of treatment. Secondary endpoints and adverse events were also examined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 226 patients who provided informed consent, 163 patients were randomized and included in the full analysis set. In the 10- and 15-mg groups, frequency of spontaneous bowel movements (\u00b1standard deviation) were significantly higher than baseline (5.7\u00a0\u00b1\u00a04.2 and 5.6\u00a0\u00b1\u00a03.5\u00a0times per week, respectively, compared with 2.6\u00a0\u00b1\u00a02.9\u00a0times per week in the placebo group [\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0005,\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0001, respectively]). Subgroup analysis indicated that elobixibat was equally effective in patients with or without constipation-predominant irritable bowel syndrome. Common adverse events included mild abdominal pain and diarrhea in the elobixibat groups; no serious or severe adverse events occurred. Elobixibat was well tolerated at once-daily oral doses up to 15\u00a0mg for 2\u00a0weeks.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our study results suggest that 10\u00a0mg of elobixibat is a clinically optimal dose for Japanese patients with chronic constipation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration number<\/jats:title>\n                    <jats:p>JapicCTI-142608.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00535-017-1383-5","type":"journal-article","created":{"date-parts":[[2017,8,24]],"date-time":"2017-08-24T05:33:05Z","timestamp":1503552785000},"page":"525-534","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":56,"title":["Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial"],"prefix":"10.1007","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6263-1436","authenticated-orcid":false,"given":"Atsushi","family":"Nakajima","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsunori","family":"Seki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Taniguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2017,8,24]]},"reference":[{"key":"1383_CR1","doi-asserted-by":"publisher","first-page":"1480","DOI":"10.1053\/j.gastro.2005.11.061","volume":"130","author":"GF Longstreth","year":"2006","unstructured":"Longstreth GF, Thompson WG, Chey WD, et al. 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