M1909 Randomized, Double-Blind Clinical Outcomes, Safety, and Tolerability Study of Pantoprazole Delayed-Release Granules in Children Aged 1 to 5 Years with Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

Abstract

G A A b st ra ct s (vomiting, dehydration, apnea, and stridor). Conclusions: In infants aged 1 through 11 mo with a clinical diagnosis of GERD, the 1.2-mg/kg equivalent dose provided statistically significant increases in mean gastric pH and percentage of time with gastric pH >4, and decreases in normalized AUC of esophageal H+ activity compared to baseline. For both doses, esophageal reflux area and normalized AUC of esophageal H+ activity decreased, indicating that the increase in the gastric pH did, in fact, result in a reduction of the pH of the refluxate. Both doses were well tolerated. The results support the choice of the 1.2mg/kg dose for infants 1 through 11 months when short-term treatment with pantoprazole is being considered.