{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:19:22Z","timestamp":1787015962783,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,2,8]],"date-time":"2019-02-08T00:00:00Z","timestamp":1549584000000},"content-version":"vor","delay-in-days":38,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatrics International"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Proton pump inhibitors (\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      ) are widely used for the treatment of gastric acid\u2010related disease, but they are not approved for use in children in Japan. To assess the safety, pharmacokinetics, pharmacodynamics, and efficacy (gastrointestinal symptom improvement) of\n                      <jats:styled-content style=\"fixed-case\">PPI<\/jats:styled-content>\n                      in Japanese pediatric patients with gastric acid\u2010related disease, we conducted an 8\u00a0week, open\u2010label, parallel\u2010group, multicenter, phase I\/\n                      <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\n                      study of once\u2010daily oral esomeprazole use.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Japanese children, aged 1\u201314\u00a0years with gastric acid\u2010related disease, were stratified by weight and age into five groups (10 patients\/group) to receive esomeprazole as granules for suspension (10\u00a0mg) or capsules (10\u00a0mg or 20\u00a0mg) once daily.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Esomeprazole was absorbed and eliminated rapidly in all groups, with a median time to reach maximum plasma concentration of 1.47\u20131.75\u00a0h, an arithmetic mean terminal elimination half\u2010life of 0.80\u20131.37\u00a0h, and a weight\u2010correlated apparent total body clearance of 0.216\u20130.343\u00a0L\/h\/kg. Area under the plasma concentration\u2013time curve during a dosage interval and maximum plasma drug concentration were generally higher in groups given a higher dose (20\u00a0mg) or with a lower age\/weight, but also in patients identified as poor metabolizers on cytochrome P450 2C19 genotype. Most patients who had any upper gastrointestinal symptoms at baseline were asymptomatic at the end of the study. Thirty\u2010three patients (66%) reported \u22651 adverse events, including three patients who reported serious adverse events not judged to be causally related to esomeprazole.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Oral esomeprazole, at 10\u00a0mg or 20\u00a0mg once daily, had a similar safety, efficacy, and pharmacokinetic profile in Japanese pediatric patients to that previously seen in adults and Caucasian children.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ped.13733","type":"journal-article","created":{"date-parts":[[2018,11,13]],"date-time":"2018-11-13T09:29:49Z","timestamp":1542101389000},"page":"87-95","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Oral esomeprazole in Japanese pediatric patients with gastric acid\u2010related disease: Safety, efficacy, and pharmacokinetics"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0364-0022","authenticated-orcid":false,"given":"Toshiaki","family":"Shimizu","sequence":"first","affiliation":[{"name":"Department of Pediatrics and Adolescent Medicine Juntendo University Graduate School of Medicine Matsumoto Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1992-6834","authenticated-orcid":false,"given":"Yoshiko","family":"Nakayama","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Shinshu University School of Medicine Matsumoto Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eizaburo","family":"Ishii","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Nagano Prefectural Suzaka Hospital Suzaka Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinobu","family":"Ida","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastroenterology Nutrition and Endocrinology, Osaka Women's and Children's Hospital Izumi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoki","family":"Satou","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Hiroshima City Funairi Citizens Hospital Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2441-5062","authenticated-orcid":false,"given":"Daisuke","family":"Tokuhara","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Osaka City University Graduate School of Medicine Abeno Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuhiro","family":"Arai","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology National Center for Child Health and Development Setagaya Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Nii","sequence":"additional","affiliation":[{"name":"Research and Development AstraZeneca Kitaku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Rydholm","sequence":"additional","affiliation":[{"name":"Global Medicine Development AstraZeneca Gothenburg M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshitaka","family":"Yajima","sequence":"additional","affiliation":[{"name":"Research and Development AstraZeneca Kitaku Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the J\u2010NEPECS (Japan Nexium Pediatrics Study) Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,2,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2006.00630.x"},{"key":"e_1_2_8_3_1","unstructured":"World Gastroenterology Organisation.World Gastroenterology Organisation Global Guidelines: GERD. Global Perspective on Gastroesophageal Reflux Disease.2015. [Cited 2018 June 4.] Available from:http:\/\/www.worldgastroenterology.org\/UserFiles\/file\/guidelines\/gastroesophagel-reflux-disease-english-2015.pdf."},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.154.2.150"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.12899"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2009.129"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e3181b7f563"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.2165\/11594360-000000000-00000"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2005.41217.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2013-0421"},{"key":"e_1_2_8_11_1","first-page":"735","article-title":"Evaluation of pharmacodynamics and pharmacokinetics of esomeprazole 10, 20 and 40\u00a0mg and omeprazole 10 and 20\u00a0mg in Japanese healthy male subjects","volume":"27","author":"Nagashima H","year":"2011","journal-title":"J. Clin. Therap. 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Dispos."},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-006-1804-3"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2005.02486.x"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-008-2214-5"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/00008571-199702000-00008"},{"key":"e_1_2_8_24_1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Clinical Investigation of Medicinal Products in the Pediatric Population E11. 2000. [Cited 2017 December 21.] Available from:http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E11\/Step4\/E11_Guideline.pdfAccessed 21 Dec 2017."}],"container-title":["Pediatrics International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fped.13733","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ped.13733","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T01:39:34Z","timestamp":1775266774000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ped.13733"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,1]]}},"alternative-id":["10.1111\/ped.13733"],"URL":"https:\/\/doi.org\/10.1111\/ped.13733","archive":["Portico"],"relation":{},"ISSN":["1328-8067","1442-200X"],"issn-type":[{"value":"1328-8067","type":"print"},{"value":"1442-200X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1]]},"assertion":[{"value":"2018-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-02-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}