To Evaluate the Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

Rabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which
suppress gastric acid secretion. The drug is approved in the United States for the treatment
of adults with GERD and other acid-related gastrointestinal disorders, and has been studied
in adolescents (older than 12 years of age) with results similar to those in adults.
However, the drug has not been studied in children under the age of 12 years. This study
focuses on the efficacy and safety of rabeprazole sodium in infants aged 1 to 11 months, the
pediatric group in which the prevalence of GERD-related symptoms is the greatest. This is a
multicenter, double-blind, randomized, placebo-controlled, parallel-group withdrawal study
to compare the efficacy and safety of 2 doses (0.5 mg/kg or 1.0 mg/kg daily) of rabeprazole
with placebo in the treatment of infants aged 1 to 11 months who have a diagnosis of
suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD. The study
consists of 3 study periods: a screening period of up to 10 days, an open-label treatment
period of up to 3 weeks, and a 5-week double-blind treatment period. Patients who have been
receiving GERD therapy before screening will have their GERD therapy discontinued for 3 days
before entering the open-label treatment period. Patients who have a positive clinical
response according to the Clinical Global Impressions - Improvement (CGI-I) scale at the end
of the first or second week of the open-label treatment period will enter the double-blind
treatment period; those who do not will be withdrawn from the study. A parent, legal
guardian, or other individual experienced in the care of the infant will be the primary
caregiver, who is responsible for the daily and weekly assessments and study drug
administration. Efficacy assessments consist of the Infant Gastroesophageal Reflux
Questionnaire Revised (I GERQ-R) total score, the Infant Gastroesophageal Reflux
Questionnaire-Daily Diary (I GERQ-DD) total score, the CGI-I, the Global Treatment
Satisfaction Score, and the weight-for-age Z-score. Safety assessments include monitoring of
concomitant therapies and adverse events throughout the study; clinical laboratory testing
(hematology, clinical chemistry, urinalysis), measurement of vital signs (pulse and
respiratory rate, blood pressure, temperature); and physical examination including length
and weight. The study hypothesis is that rabeprazole sodium is superior to placebo in the
treatment of GERD in infants aged 1 to 11 months. Rabeprazole sodium capsule(s) by mouth
once a day, 10.0 milligram (mg)/kilogram (kg) for up to 3 weeks during the open-label
treatment period and either 5.0 mg/kg or 10.0 mg/kg during the 5-week double-blind treatment
period. To give the study drug to the infants, the contents of the capsule(s) are sprinkled
onto a small amount of soft food or, as needed, the contents of the capsule(s) may be given
in a small amount (5 milliliter [mL]) of infant formula or expressed breast milk.