Status:
COMPLETED
A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Eisai Inc.
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
1-11 years
Phase:
PHASE1
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 th...
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 dr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00747526
Start Date
December 1 2007
End Date
February 1 2012
Last Update
July 8 2013
Active Locations (20)
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1
Little Rock, Arkansas, United States
2
Oakland, California, United States
3
Washington D.C., District of Columbia, United States
4
Maitland, Florida, United States