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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed-Release Rabeprazole in 1- to 11-Month-Old Pediatric Subject...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-004847-12

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed-Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects with Symptomatic/Erosive Gastroesophageal Reflux Disease (GERD)

Femme et Homme

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Extrait

To determine the efficacy and overall safety of rabeprazole sodium at doses of 5.0 mg and 10.0 mg relative to placebo in infant subjects with GERD who are 1 to 11 months of age at screening. The primary efficacy endpoint will be measured by the changes from baseline to the end of the study in the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) total score and the Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) total score between the active treatment and placebo groups.

Critère d'inclusion

  • Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 month old subjects

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