A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Rabeprazole sodium 5 mg (Drug); Rabeprazole sodium 10 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Development, L.L.C. Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
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).
Clinical Details
Official title: A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects With GERD 1 to 11 Months Old, Inclusive
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic parametersPharmacodynamic parameters
Secondary outcome: Number of Patients with Adverse Events as a Measure of Safety
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.
Eligibility
Minimum age: 1 Month.
Maximum age: 11 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Minimum weight of 5 kg (treatment Option 1) or 3 kg (treatment Option 2) with a
diagnosis of GERD
- Informed consent signed by at least one parent
- Patients who have been treated with, or are currently receiving a proton pump
inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off
antacids for 24 hours, and PPIs and H2 blockers for three days prior to dosing,
except for cimetidine, which must be discontinued for at least seven days prior to
dosing) and remain off these medications for the treatment period
Exclusion Criteria:
- Patients who have history of or current clinically significant medical illness
(excluding GERD) including (but not limited to) cardiac arrhythmias or other cardiac
disease, hematologic disease, coagulation disorders (including any abnormal bleeding
or blood dyscrasias), lipid abnormalities, diabetes mellitus, renal or hepatic
insufficiency, thyroid disease, infection, or any other illness that the investigator
considers should exclude the patient or that could interfere with the interpretation
of the study results
- Primary pulmonary or ears, nose, and throat (ENT) symptoms
- History of or current presence of peptic ulcers
- Presence of "warning signals", suggesting cause of vomiting/regurgitation other than
GERD
- Any condition which would make the patient, in the opinion of the Investigator or
Sponsor, unsuitable for the study
Locations and Contacts
Antwerpen, Belgium
Brussel, Belgium
Sao Paulo, Brazil
Lublin, Poland
Warszawa, Poland
Barnsley N/A, United Kingdom
London, United Kingdom
Little Rock, Arkansas, United States
Oakland, California, United States
Washington, District of Columbia, United States
Maitland, Florida, United States
Louisville, Kentucky, United States
Jackson, Mississippi, United States
Bridgeton, Missouri, United States
Long Branch, New Jersey, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Youngstown, Ohio, United States
Houston, Texas, United States
Additional Information
A Pharmacokinetic, Pharmacodynamic, and Safety Study of Single- and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months old, Inclusive
Starting date: December 2007
Last updated: July 5, 2013
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