{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:03:00Z","timestamp":1792684980791,"version":"4.5.0"},"reference-count":37,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and aims<\/jats:title>\n                    <jats:p>\n                      No medications are currently approved for the prevention of recurrent acute pancreatitis. This trial evaluated whether naldemedine, a peripherally acting\n                      <jats:italic>\u03bc<\/jats:italic>\n                      \u2010opioid receptor antagonist, reduces the risk of acute pancreatitis in patients with recurrent acute pancreatitis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicentre, double\u2010blinded, placebo\u2010controlled randomised trial conducted at four Danish pancreatitis referral centres. Participants aged 18\u201375\u00a0years with recurrent acute pancreatitis, both with and without a diagnosis of chronic pancreatitis, were randomised to receive naldemedine 0.2\u00a0mg or a matching placebo daily for up to 12\u00a0months. The primary outcome was acute pancreatitis recurrence, defined by the revised Atlanta Criteria. Secondary outcomes included pain flares, gastrointestinal symptoms, and quality of life. At the end of follow\u2010up, the participant's global impression of change, safety and tolerability outcomes, new\u2010onset diabetes and pancreatic exocrine insufficiency were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      74 participants (mean age: 46\u00a0years; 41% female) were randomised to naldemedine (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a036) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a038). During a median follow\u2010up time of 365\u00a0days (IQR, 352\u2013370), participants in the naldemedine group had a numerically lower risk of acute pancreatitis compared to placebo (HR 0.54; 95% CI, 0.29\u20131.01;\n                      <jats:italic>p\u00a0=<\/jats:italic>\n                      \u00a00.05). No differences were observed between the groups for secondary efficacy, safety, and tolerability outcomes. Participants treated with naldemedine for at least 1\u00a0year had a lower risk of acute pancreatitis (HR 0.49; 95% CI, 0.24\u20130.97;\n                      <jats:italic>p\u00a0=<\/jats:italic>\n                      \u00a00.04).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Treatment with naldemedine was safe and well\u2010tolerated and may reduce the risk of recurrent acute pancreatitis. A larger confirmatory trial is needed to verify these findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      Identifier: PAMORA\u2010RAP: NCT04966559\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ueg2.70178","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T17:10:46Z","timestamp":1768842646000},"source":"Crossref","is-referenced-by-count":6,"title":["Naldemedine for the Prevention of Recurrent Acute Pancreatitis: A Randomised, Double\u2010Blind, Placebo\u2010Controlled Trial"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4157-1091","authenticated-orcid":false,"given":"Mathias E.","family":"Cook","sequence":"first","affiliation":[{"name":"Centre for Pancreatic Diseases and Mech\u2010Sense Department of Gastroenterology and Hepatology Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8373-1487","authenticated-orcid":false,"given":"Cecilie S.","family":"Knoph","sequence":"additional","affiliation":[{"name":"Centre for Pancreatic Diseases and Mech\u2010Sense Department of Gastroenterology and Hepatology Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1120-8144","authenticated-orcid":false,"given":"Line","family":"Davidsen","sequence":"additional","affiliation":[{"name":"Centre for Pancreatic Diseases and Mech\u2010Sense Department of Gastroenterology and Hepatology Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8722-0070","authenticated-orcid":false,"given":"Jens B.","family":"Fr\u00f8kj\u00e6r","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"},{"name":"Department of Radiology Aalborg University Hospital  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2644-4115","authenticated-orcid":false,"given":"Niels H.","family":"Bruun","sequence":"additional","affiliation":[{"name":"Research Data and Biostatistics Aalborg University Hospital  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6246-874X","authenticated-orcid":false,"given":"Srdan","family":"Novovic","sequence":"additional","affiliation":[{"name":"Gastrounit Copenhagen University Hospital Hvidovre  Hvidovre Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amer","family":"Hadi","sequence":"additional","affiliation":[{"name":"Gastrounit Copenhagen University Hospital Hvidovre  Hvidovre Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-1874-0012","authenticated-orcid":false,"given":"Maiken Thyregod","family":"J\u00f8rgensen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine SLB Vejle Hospital  Vejle Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7270-5005","authenticated-orcid":false,"given":"Michael B.","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Odense Pancreas Centre (OPAC) HPB Section Department of Surgery Odense University Hospital  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1969-2329","authenticated-orcid":false,"given":"Ove","family":"Schaffalitzky","sequence":"additional","affiliation":[{"name":"Odense Pancreas Centre (OPAC) HPB Section Department of Surgery Odense University Hospital  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liv B. J.","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Digestive Disease Centre K Copenhagen University Hospital Centre  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1305-3382","authenticated-orcid":false,"given":"Mark","family":"Berner\u2010Hansen","sequence":"additional","affiliation":[{"name":"Digestive Disease Centre K Copenhagen University Hospital Centre  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7465-964X","authenticated-orcid":false,"given":"Asbj\u00f8rn M.","family":"Drewes","sequence":"additional","affiliation":[{"name":"Centre for Pancreatic Diseases and Mech\u2010Sense Department of Gastroenterology and Hepatology Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3916-3168","authenticated-orcid":false,"given":"S\u00f8ren S.","family":"Olesen","sequence":"additional","affiliation":[{"name":"Centre for Pancreatic Diseases and Mech\u2010Sense Department of Gastroenterology and Hepatology Aalborg University Hospital  Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,19]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.09.043"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002645"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620\u2010017\u20104510\u20105"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.08.042"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.16453"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2016.02.001"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.07.066"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2017.218"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.10.001"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/mog.0000000000000563"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12641"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2023.12.011"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sjpain.2015.12.005"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2023.09.141"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.11.081"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467\u2010018\u201004194\u20109"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002887"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063\u2010023\u201007287\u2010z"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102012\u2010302779"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1093\/pm\/pnw325"},{"key":"e_1_2_11_22_1","unstructured":"Sealed Envelope Ltd.Simple Randomisation Service.2022 https:\/\/www.sealedenvelope.com\/simple\u2010randomiser\/v1\/."},{"key":"e_1_2_11_23_1","unstructured":"Sundhedsstyrelsen (in Danish).Anbefalinger Om Alkohol.2022 https:\/\/sst.dk\/da\/borger\/en\u2010sund\u2010hverdag\/alkohol\/anbefalinger\u2010om\u2010alkohol."},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535\u2010006\u20101945\u20104"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/0021\u20109681(87)90171\u20108"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2025.04.020"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.3109\/00365529609095544"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.3109\/00365529709011203"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0304\u20103959(01)00349\u20109"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.07.025"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.07.007"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2020.00494"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2022.05.002"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/mpa.0000000000001174"},{"key":"e_1_2_11_36_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002772"},{"key":"e_1_2_11_37_1","doi-asserted-by":"publisher","DOI":"10.1097\/pr9.0000000000000625"},{"key":"e_1_2_11_38_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjs\/znad318"}],"container-title":["United European Gastroenterology Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ueg2.70178","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ueg2.70178","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ueg2.70178","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,26]],"date-time":"2026-05-26T09:12:55Z","timestamp":1779786775000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ueg2.70178"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,19]]},"references-count":37,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1002\/ueg2.70178"],"URL":"https:\/\/doi.org\/10.1002\/ueg2.70178","archive":["Portico"],"relation":{},"ISSN":["2050-6406","2050-6414"],"issn-type":[{"value":"2050-6406","type":"print"},{"value":"2050-6414","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,19]]},"article-number":"e70178"}}