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.

Abstract	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.
Authors	Robert Baker, V Marc Tsou, John Tung, Susan Sestini Baker, Huihua Li, Wenjin Wang, Natalie Rath, Mary K Maguire, Gail M Comer
Journal	Clinical pediatrics (Clin Pediatr (Phila)) Vol. 49 Issue 9 Pg. 852-65 (Sep 2010) ISSN: 1938-2707 [Electronic] United States
PMID	20522615 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	2-Pyridinylmethylsulfinylbenzimidazoles Delayed-Action Preparations Proton Pump Inhibitors Pantoprazole
Topics	2-Pyridinylmethylsulfinylbenzimidazoles (administration & dosage, adverse effects, therapeutic use) Biopsy Canada Child Child, Preschool Delayed-Action Preparations (administration & dosage, adverse effects, therapeutic use) Dose-Response Relationship, Drug Double-Blind Method Esophagitis, Peptic (drug therapy, pathology) Esophagoscopy Female Gastroesophageal Reflux (drug therapy) Humans Infant Male Medical Records Pantoprazole Proton Pump Inhibitors (administration & dosage, adverse effects, therapeutic use) Surveys and Questionnaires Treatment Outcome United States

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.

Realize the full power of the drug-disease research graph!