| Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. | |
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MedLine Citation:
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PMID: 20522615 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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In an 8-week, multicenter, randomized, double-blind study, we evaluated the efficacy and tolerability of pantoprazole (0.3mg/kg [low dose (LD)], 0.6 mg/kg [medium dose (MD)], and 1.2 mg/kg [high dose (HD)]) for delayed-release oral suspension (granules) in patients 1 to 5 years with documented symptoms of gastroesophageal reflux disease (GERD) and endoscopic evidence of reflux-related erosive esophagitis (EE) or histologic esophagitis (HE) consistent with GERD. Patients with HE were randomly assigned to LD, MD, or HD, and patients with EE, to MD or HD. A daily eDiary captured 5 individual GERD symptoms. A total of 60 patients (56 HE, 4 EE) were randomized. Mean weekly GERD symptom score (WGSS, sum of weekly mean frequency scores for 5 individual GERD symptoms) for the modified intention-to-treat HE population at the final week was improved with LD ( P < .001), MD (P = .063), and HD (P < 0.001) (paired t-tests). Patients with EE were healed at week 8. Adverse event incidences did not increase with dose. |
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Authors:
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Robert Baker; V Marc Tsou; John Tung; Susan Sestini Baker; Huihua Li; Wenjin Wang; Natalie Rath; Mary K Maguire; Gail M Comer |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2010-06-03 |
Journal Detail:
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Title: Clinical pediatrics Volume: 49 ISSN: 1938-2707 ISO Abbreviation: Clin Pediatr (Phila) Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-08-09 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372606 Medline TA: Clin Pediatr (Phila) Country: United States |
Other Details:
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Languages: eng Pagination: 852-65 Citation Subset: AIM; IM |
Affiliation:
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Women and Children's Hospital of Buffalo, Buffalo, NY, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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