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
| Autor: | Susan S. Baker, Wenjin Wang, V. Marc Tsou, Mary K. Maguire, Huihua Li, Robert D. Baker, Natalie Rath, John Tung, Gail M. Comer |
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| Rok vydání: | 2010 |
| Předmět: |
Male
Canada medicine.medical_specialty Biopsy Population Gastroenterology 2-Pyridinylmethylsulfinylbenzimidazoles Medical Records Double-Blind Method Surveys and Questionnaires Internal medicine medicine Humans Child education Adverse effect Esophagitis Peptic Pantoprazole education.field_of_study Dose-Response Relationship Drug business.industry Reflux Infant Proton Pump Inhibitors medicine.disease Dose-ranging study United States digestive system diseases Treatment Outcome Tolerability Child Preschool Delayed-Action Preparations Pediatrics Perinatology and Child Health Gastroesophageal Reflux GERD Female Esophagoscopy business Esophagitis medicine.drug |
| Zdroj: | Clinical Pediatrics. 49:852-865 |
| ISSN: | 1938-2707 0009-9228 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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