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A phase III, Multicenter, Randomzed, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophag...

Update Il y a 4 ans
Reference: EUCTR2006-005212-27

A phase III, Multicenter, Randomzed, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Infants Aged 1 to 11 months, Inclusive

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Extract

The primary objective of this study is to evaluate the efficacy of once daily esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile GERD.

Inclusion criteria

  • This Phase III study will evaluate esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile gastro-esophageal reflux disease (GERD) in infants aged 1 to 11 months, inclusive

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