A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months old, Inclusive - N/A

Janssen-Cilag International N.V.0 sites49 target enrollmentMarch 15, 2010

ConditionsPediatric subjects with GERD MedDRA version: 13.1 Level: LLT Classification code 10018203 Term: GERD System Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pediatric subjects with GERD
Sponsor: Janssen-Cilag International N.V.
Enrollment: 49
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 15, 2010

End Date

February 29, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Janssen-Cilag International N.V.

Eligibility Criteria

Inclusion Criteria

•Subjects must satisfy the following criteria to be enrolled in the study:
•1\.Boys or girls, ages 1 to 11 months (up to 11 months 29 days), inclusive, and a minimum weight of 5 kg (treatment Option 1\) or 3 kg (treatment Option 2\)with a diagnosis of GERD.
•2\.As approved by institutional specific guidelines, the subject’s parent (preferably both parents if available) must sign an informed consent form before the performance of any study procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
•3\.The subject’s parent (preferably both parents if available), must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study
•4\.Subjects who have been treated with, or are currently receiving 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
•5\.The subject’s parent must be willing to adhere to prohibitions and restrictions outlined in the protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 33
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 0

Exclusion Criteria

•Subjects who meet any of the following criteria will be excluded from participating in the study:
•1\.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 subject or that could interfere with the interpretation of the study results
•2\.Primary pulmonary or ENT symptoms, eg, bronchospasm, aspiration pneumonia, chronic nasal blockage, cough, recurrent croup\-like cough, stridor, hoarseness, laryngitis, recurrent bronchitis, laryngospasm, nocturnal asthma, bronchopulmonary dysplasia which are primary disease processes and not deemed to be secondary to GERD
•3\.Presence of warning signals”, eg, bilious vomiting, GI bleeding (hematemesis, hematochezia), forceful vomiting, fever, lethargy, hepatosplenomegaly, urinary tract infections, macro/microcephaly, seizures, genetic disorders (eg, trisomy 21\), suggesting cause of vomiting/regurgitation other than GERD
•4\.History of or current presence of peptic ulcers
•5\.Uncorrected electrolyte disorders (such as hypokalemia, hypocalcemia, hypomagnesemia with normal reference for age)
•6\.Known chromosome abnormality or congenital anomalies of the gastrointestinal tract, heart or liver; including, eg, obstruction, atresias (other than gastrointestinal tract immaturity)
•7\.Serum concentrations of hepatic transaminases \> 3\-fold higher than the upper limit of normal for age and/or creatinine values \= 106 µmol/L (\> 1\.2 mg/dl)
•8\.Clinically relevant laboratory values outside the normal age appropriate range. If the results of the testing are not within the laboratory’s reference range for the subject’s age, the subject may be included only if the investigator decides the abnormal values are not clinically significant. Laboratory results taken from the subject’s history if performed within 48 hours prior to screening are allowed, in lieu of a laboratory draw
•9\.Participation in any investigational drug or medical device trial prior to selection within 30 days or within a period less than 10 times the drug’s half life, whichever is longer, before the first dose of the study drug is scheduled