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 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.
Baker
Robert
R
Women and Children's Hospital of Buffalo, Buffalo, NY, USA.
Tsou
V Marc
VM
Tung
John
J
Baker
Susan Sestini
SS
Li
Huihua
H
Wang
Wenjin
W
Rath
Natalie
N
Maguire
Mary K
MK
Comer
Gail M
GM
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D002170:Canada; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D004945:Esophagoscopy; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D008499:Medical Records; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D003692:Delayed-Action Preparations; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole