Study conducted and completed to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
Study Question: In premature infants with apnea and/or bradycardia attributed to gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and motility agents), compared to placebo, reduce the frequency of apnea and bradycardia?"
Study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
Study is to evaluate the pharmacokinetics (blood levels), pharmacodynamics (how the drug acts on the body), and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in new borns and pre-term infants (less than 44 weeks of age).
Purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid
secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.