A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, in...

Update Il y a 4 ans
Reference: EUCTR2006-002001-31

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age

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Extract

The primary objective of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms of GERD as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


Inclusion criteria

  • This prospective study will evaluate the efficacy and safety of esomeprazole for the treatment of GERD in neonatal patients