A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Years old, inclusive

• Conditions: Pediatric subjects with GERD (endoscopically proven) and have had endoscopic examination as part of their diagnostic evaluation; MedDRA version: 9.1Level: LLTClassification code 10018203Term: GERD; 1 to 11 Years Old, inclusive

• Registration Number: EUCTR2008-000451-97-BE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Boys or girls, ages 1 to 11 years (up to 11 years 364 days), inclusive, at
the time of first dose, and a minimum weight of 10 kg with endoscopically-proven GERD including an endoscopic examination as part of their diagnostic evaluation. This endoscopic examination may be from a diagnosis made prior to the initiation of an ongoing treatment of the subject’s GERD, or from a diagnosis made just prior to enrollment in the study. Girls must be premenarchal.
2. As approved by institutional specific guidelines, a 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. Children who are capable of providing assent (typically 7 years of age and older) must sign an assent 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. Subjects 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;
4. Subjects should be generally healthy, other than the presence of GERD,
with the exception of the following:
a. Subjects with stable asthma/reactive airway disease or cystic fibrosis-dependent GERD symptoms on stable treatment regimens
b. Subjects on stable doses of allergy and attention deficit disorder medicines
5. Subjects 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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of or current clinically significant medical illness (excluding GERD, asthma/reactive airway disease or cystic fibrosis-dependent 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, neurologic or psychiatric 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, onset of vomiting after 6 years of life, 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 primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections)
5. History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy
6. History of or current presence of peptic ulcers
7. Current presence of Helicobacter pylori
8. History of definitive acid-lowering surgery
9. Significant arrhythmias, including ventricular arrhythmias, second or third degree atrioventricular block, congestive heart failure or ischemic heart disease, ventricular tachycardia, torsades de pointes
10. History of significant arrhythmias in siblings or primary family members
11. History of sudden infant death in a sibling, and/or history of a serious apparent life threatening event in the subject or sibling
12. Clinically significant bradycardia (heart rate <80 bpm;), affecting hemodynamic function not due to feeding difficulties
13. Uncorrected electrolyte disorders (such as hypokalemia, hypocalcemia, hypomagnesemia with normal reference for age)
14. Known chromosome abnormality or congenital anomalies of the gastrointestinal tract, heart or liver; including, eg, obstruction, atresias (other than gastrointestinal tract immaturity)
15. Serum concentrations of hepatic transaminases >3-fold higher than the upper limit of normal for age and/or creatinine > = 106 mmoles/L
16. 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
17. 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
18. Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study
19. Treatment with full therapeutic doses of H2-r

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the pharmacokinetics, pharmacodynamics (clinical global impressions and formulation palatability) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 to 11 years, inclusive (up to 11 years 364 days), with GERD. <br>As this study is an exploratory assessment of the pharmacokinetics, pharmacodynamics, and safety of rabeprazole in children, no formal hypothesis testing is applied. ;Secondary Objective: none;Primary end point(s): Not applicable, No primary end point is speficied for this study. This is an exploratory study, several end points will be investigated (PK, PD and safety measures).