{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T00:18:02Z","timestamp":1781914682892,"version":"3.54.5"},"reference-count":29,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2017,10,25]],"date-time":"2017-10-25T00:00:00Z","timestamp":1508889600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin and is approved in the United States for adults with chronic idiopathic constipation (CIC). This double-blind, placebo-controlled, phase III study evaluated the efficacy and safety of plecanatide versus placebo in CIC. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg ( n = 443), 6 mg ( n = 449), or placebo ( n = 445). Patients recorded bowel movement (BM) characteristics [including spontaneous BMs (SBMs) and complete SBMs (CSBMs)] and rated CIC symptoms in daily electronic diaries. The primary endpoint was the percentage of durable overall CSBM responders (weekly responders for \u2a7e9 of 12 treatment weeks, including \u2a7e3 of the last 4 weeks). Weekly responders had \u2a7e3 CSBMs\/week and an increase of \u2a7e1 CSBM from baseline for the same week. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> A significantly greater percentage of durable overall CSBM responders resulted with each plecanatide dose compared with placebo (3 mg = 20.1%; 6 mg = 20.0%; placebo = 12.8%; p = 0.004 each dose). Over the 12 weeks, plecanatide significantly improved stool consistency and stool frequency. Significant increases in mean weekly SBMs and CSBMs began in week 1 and were maintained through week 12 in plecanatide-treated patients. Adverse events were mostly mild\/moderate, with diarrhea being the most common (3 mg = 3.2%; 6 mg = 4.5%; placebo = 1.3%). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p> Plecanatide resulted in a significantly greater percentage of durable overall CSBM responders and improved stool frequency and secondary endpoints. Plecanatide was well tolerated; the most common AE, diarrhea, occurred in a small number of patients. [ClinicalTrials.gov identifier: NCT02122471] <\/jats:p><\/jats:sec>","DOI":"10.1177\/1756283x17734697","type":"journal-article","created":{"date-parts":[[2017,10,25]],"date-time":"2017-10-25T09:20:38Z","timestamp":1508923238000},"page":"837-851","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":71,"title":["Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation"],"prefix":"10.1177","volume":"10","author":[{"given":"Michael","family":"DeMicco","sequence":"first","affiliation":[{"name":"Anaheim Clinical Trials, Anaheim, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Barrow","sequence":"additional","affiliation":[{"name":"Synergy Pharmaceuticals Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernadette","family":"Hickey","sequence":"additional","affiliation":[{"name":"Synergy Pharmaceuticals Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunwar","family":"Shailubhai","sequence":"additional","affiliation":[{"name":"Synergy Pharmaceuticals Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Griffin","sequence":"additional","affiliation":[{"name":"Executive Vice President and Chief Medical Officer, Synergy Pharmaceuticals Inc., 420 Lexington Avenue, Suite 2012, New York, NY 10170, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,10,25]]},"reference":[{"key":"bibr1-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2005.50613_2.x"},{"key":"bibr2-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2015.67"},{"key":"bibr3-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.164"},{"key":"bibr4-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2013.860375"},{"key":"bibr5-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.01.003"},{"key":"bibr6-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.95.4.1466"},{"key":"bibr7-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1159\/000335767"},{"key":"bibr8-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2010.09.019"},{"key":"bibr9-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.4292\/wjgpt.v6.i4.213"},{"key":"bibr10-1756283X17734697","first-page":"3777","volume":"29","author":"Liu D","year":"2009","journal-title":"Anticancer Res"},{"key":"bibr11-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-013-2684-z"},{"key":"bibr12-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(13)60585-5"},{"key":"bibr13-1756283X17734697","volume-title":"Poster presented at Digestive Disease Week (DDW)","author":"Shailubhai K","year":"2010"},{"key":"bibr14-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2016.611"},{"key":"bibr15-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.3109\/00365529709011203"},{"key":"bibr16-1756283X17734697","first-page":"332","volume":"108","author":"Mearin F","year":"2016","journal-title":"Rev Esp Enferm Dig"},{"key":"bibr17-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000000595"},{"key":"bibr18-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0134349"},{"key":"bibr19-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010863"},{"key":"bibr20-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0800670"},{"key":"bibr21-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2008.162404"},{"key":"bibr22-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2008.03884.x"},{"key":"bibr23-1756283X17734697","first-page":"F342","volume":"266","author":"Kita T","year":"1994","journal-title":"Am J Physiol"},{"key":"bibr24-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.94.6.2705"},{"key":"bibr25-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.14309\/00000434-201210001-01725"},{"key":"bibr26-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.10.029"},{"key":"bibr27-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1152\/ajpcell.00528.2003"},{"key":"bibr28-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.3390\/toxins2092213"},{"key":"bibr29-1756283X17734697","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.00639-16"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X17734697","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1756283X17734697","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X17734697","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,2]],"date-time":"2025-03-02T18:08:34Z","timestamp":1740938914000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1756283X17734697"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,10,25]]},"references-count":29,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2017,11]]}},"alternative-id":["10.1177\/1756283X17734697"],"URL":"https:\/\/doi.org\/10.1177\/1756283x17734697","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,10,25]]}}}