The primary objective of the pediatric development program was to evaluate the safety profile of NEXIUM in patients 1 to 11 years of age1
Experience with NEXIUM in pediatric patients with erosive esophagitis (EE)
Data from a phase III, multicenter, randomized, open-label to treatment, double-blinded to dose, parallel-group study evaluating the safety and clinical outcome of NEXIUM in patients aged 1 to 11 years with GERD, treated once daily with NEXIUM 5 mg, NEXIUM 10 mg, or NEXIUM 20 mg for 8 weeks. Dosing was determined by patient weight. A total of 109 patients of both sexes with endoscopically proven GERD were enrolled, with 101 patients completing the study. Of the 109 patients, 53 had EE at baseline (51 had mild, 1 moderate, and 1 severe).1
Patients were considered healed if their final follow-up endoscopy showed no signs of erosions.
†Among all patients studied who had a follow-up endoscopy (n=45), overall resolution of EE was 88.9% (n=40) across varying grades of EE.
1. Data on file, eSTaR #263720.
2. Prescribing Information for NEXIUM, AstraZeneca Pharmaceuticals LP, Wilmington, DE.
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