{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T17:44:47Z","timestamp":1792604687726,"version":"4.5.0"},"reference-count":32,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2007,11,1]],"date-time":"2007-11-01T00:00:00Z","timestamp":1193875200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. pediatr. gastroenterol. nutr."],"published-print":{"date-parts":[[2007,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>The primary objective was to assess the safety of esomeprazole 20 or 40 mg once daily in adolescents with clinically diagnosed gastroesophageal reflux disease (GERD). A secondary aim was to assess changes in GERD symptoms after esomeprazole therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods:<\/jats:title>\n                    <jats:p>In this multicenter, randomized, double\u2010blind study, adolescents ages 12 to 17 years inclusive received esomeprazole 20 or 40 mg once daily for 8 weeks. Adverse events and changes in clinical parameters (eg, physical examination, laboratory measurements) were evaluated to assess safety. Patients or their parents or guardians scored symptom severity daily, and investigators scored overall GERD symptom severity every 2 weeks using a 4\u2010point scale.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      In the 148 adolescents with safety data, treatment\u2010related and non\u2013treatment\u2010related adverse events were reported by 75% and 78% of patients in the esomeprazole 20\u2010 and 40\u2010mg groups, respectively. Twenty\u2010two patients (14.9%) experienced adverse events that were considered related to treatment; the most common were headache (8%, 12\/148), abdominal pain (3%, 4\/148), nausea (2%, 3\/148), and diarrhea (2%, 3\/148). No serious adverse events or clinically important findings in other safety assessments were observed. At baseline, 68% (100\/147) had heartburn, 63% (93\/147) had epigastric pain, 57% (84\/147) had acid regurgitation, and 15% (22\/147) had vomiting symptoms. Symptom scores decreased significantly in both the esomeprazole 20\u2010mg and 40\u2010mg groups by the final study week (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.0001). Investigators rated 63.1% (94\/149) of the patients as having moderate or severe symptoms at baseline; at the final visit, this percentage decreased significantly to 9.3% (13\/140;\n                      <jats:italic>P<\/jats:italic>\n                      &lt; .0001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In adolescent patients with GERD, esomeprazole 20 or 40 mg daily for 8 weeks was well tolerated, and GERD\u2010related symptoms were significantly reduced from baseline values in both groups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1097\/mpg.0b013e318148c17c","type":"journal-article","created":{"date-parts":[[2009,3,3]],"date-time":"2009-03-03T17:50:13Z","timestamp":1236102613000},"page":"520-529","source":"Crossref","is-referenced-by-count":42,"title":["Safety and Symptom Improvement With Esomeprazole in Adolescents With Gastroesophageal Reflux Disease"],"prefix":"10.1002","volume":"45","author":[{"given":"Benjamin D","family":"Gold","sequence":"first","affiliation":[{"name":"Division of Pediatric Gastroenterology and Nutrition Emory University School of Medicine Atlanta GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thirumazhisai","family":"Gunasekaran","sequence":"additional","affiliation":[{"name":"Center for Children's Digestive Health Lutheran General Children's Hospital Park Ridge IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasundhara","family":"Tolia","sequence":"additional","affiliation":[{"name":"Wayne State University Detroit MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graciela","family":"Wetzler","sequence":"additional","affiliation":[{"name":"Maimonides Infants &amp; 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