A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the
      body, how it is distributed within the body and removed from the body over time),
      pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after
      single and multiple daily administration in infants between the ages of 1 and 11 months,
      inclusive, with Gastroesophageal Reflux Disease (GERD).
    

Detailed description: 
      This is an open-label (both physician and patient know the name of the study medication),
      multicenter, Phase I study, consisting of 2 parts. The first part of the study will be
      nonrandomized (study drug is intentionally assigned), and all patients will receive the same
      dose. In the second part of the study, patients will be randomized (study medication assigned
      by chance) into 2 dose groups. The purpose of the study is to evaluate the pharmacokinetics
      (PK), pharmacodynamics (intraesophageal/intragastric pH, clinical global impression,
      formulation palatability and Gastroesophageal Reflux Disease (GERD) daily symptom diary) and
      safety of rabeprazole after single and multiple daily administration at 2 dose levels in
      children between the ages of 1 and 11 months, inclusive (up to 11 months 29 days), with GERD.
      As this study is an exploratory assessment of the PK, pharmacodynamics and safety of
      rabeprazole in children, no formal hypothesis testing is applied. Safety and tolerability,
      including monitoring of adverse events, clinical laboratory results, physical examination,
      vital signs and electrocardiogram measurements (the measuring of the electrical currents in
      the heart), will be evaluated throughout the study. Patients will receive rabeprazole sodium
      as single daily oral doses for 5 successive days (Option 1), or up to 14 successive days (10
      days minimum) (Option 2) as a bead formulation. In Part 1, patients will receive single and
      multiple daily (every 24 hours) doses of 0.5 mg/kg, using increments of 1 mg dose. Safety and
      PK data from Part 1 of the study will determine the 2 dosages to be studied in Part 2 of the
      study. In Part 2, patients may receive rabeprazole sodium as single daily oral doses for up
      to a maximum of 28 consecutive days as a bead formulation. Patients will be randomized into
      either the 5 mg dose or 10 mg dose group.
    

Intervention name(s): Rabeprazole sodium 5 mg; Rabeprazole sodium 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Type= exact number, unit= mg, number= 5, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to Day 5; possible extension using 5 mg once daily up to 28 consecutive days.; Type= exact number, unit= mg, number= 10, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to up to Day 14; possible extension using 10 mg once daily up to 28 consecutive days.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease (GERD); Pediatrics; Pharmacokinetics; Pharmacodynamics; Rabeprazole; GERD; Aciphex