A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects With GERD 1 to 11 Months Old, Inclusive
3 other identifiers
interventional
51
5 countries
20
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2007
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJuly 8, 2013
July 1, 2013
4.2 years
September 4, 2008
July 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic parameters
At Days 1, 5, and 10
Pharmacodynamic parameters
At Days 1, 5, and 10
Secondary Outcomes (1)
Number of Patients with Adverse Events as a Measure of Safety
Approximately 9 weeks
Study Arms (2)
Rabeprazole sodium 5 mg
EXPERIMENTALRabeprazole sodium 10 mg
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Eisai Inc.collaborator
Study Sites (20)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Bridgeton, Missouri, United States
Unknown Facility
Long Branch, New Jersey, United States
Unknown Facility
Greenville, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Youngstown, Ohio, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
São Paulo, Brazil
Unknown Facility
Lublin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Barnsley, United Kingdom
Unknown Facility
London, United Kingdom
Related Publications (1)
Treem W, Hu P, Sloan S. Normal and proton pump inhibitor-mediated gastrin levels in infants 1 to 11 months old. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):520-6. doi: 10.1097/MPG.0b013e31829b6914.
PMID: 23689261DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Development, L.L.C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 5, 2008
Study Start
December 1, 2007
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
July 8, 2013
Record last verified: 2013-07