Femme et Homme
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Extrait
The primary objectives of this study are to evaluate the efficacy(endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg [10 mg max dose] and 1.0 mg/kg [20 mg max dose]) of a pediatric bead formulation of rabeprazole sodium (which can be administered orally mixed with food as needed) in a 12-week, parallel-group, double-blind design followed by a long-term safety and efficacy assessment in a 24-week, double-blind maintenance treatment phase in subjects, 1 to11 years of age, with endoscopically proven GERD.
Critère d'inclusion
- Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects