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

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 sympt...

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Bibliographic Details
Published in:Clinical pediatrics 2010-09, Vol.49 (9), p.852-865
Main Authors: Baker, Robert, Tsou, V.Marc, Tung, John, Sestini Baker, Susan, Huihua Li, Wenjin Wang, Rath, Natalie, Maguire, Mary K., Comer, Gail M.
Format: Article
Language:English
Subjects:
2-Pyridinylmethylsulfinylbenzimidazoles - administration & dosage
2-Pyridinylmethylsulfinylbenzimidazoles - adverse effects
2-Pyridinylmethylsulfinylbenzimidazoles - therapeutic use
Biopsy
Canada
Child
Child, Preschool
Clinical trials
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Delayed-Action Preparations - therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Drug therapy
Esophagitis, Peptic - drug therapy
Esophagitis, Peptic - pathology
Esophagoscopy
Esophagus
Female
Gastroenterology
Gastroesophageal reflux
Gastroesophageal Reflux - drug therapy
Humans
Infant
Inhibitor drugs
Male
Medical Records
Proton Pump Inhibitors - administration & dosage
Proton Pump Inhibitors - adverse effects
Proton Pump Inhibitors - therapeutic use
Surveys and Questionnaires
Treatment Outcome
United States
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Summary: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.
ISSN:0009-9228
1938-2707
DOI:10.1177/0009922810369253