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

Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.

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.

Trial registration: ClinicalTrials.gov NCT00300755.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage
  • 2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use*
  • Biopsy
  • Canada
  • Child
  • Child, Preschool
  • Delayed-Action Preparations / administration & dosage
  • Delayed-Action Preparations / adverse effects
  • Delayed-Action Preparations / therapeutic use
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Esophagitis, Peptic / drug therapy*
  • Esophagitis, Peptic / pathology
  • Esophagoscopy
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Infant
  • Male
  • Medical Records
  • Pantoprazole
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / adverse effects
  • Proton Pump Inhibitors / therapeutic use*
  • Surveys and Questionnaires
  • Treatment Outcome
  • United States

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Delayed-Action Preparations
  • Proton Pump Inhibitors
  • Pantoprazole

Associated data

  • ClinicalTrials.gov/NCT00300755