Study of Rabeprazole in Pediatric Subjects aged 1 to 11 months with acid reflux disease
- Conditions
- Pediatric subjects with GERDMedDRA version: 13.1 Level: LLT Classification code 10018203 Term: GERD System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2008-000452-27-GB
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 49
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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
10.Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study
11.Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor), except for cimetidine, which must be discontinued for at least seven days prior to dosing
12.Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter washout if agreed to by Investigator and sponsor)
13.A history of allergy/sensitivity to proton pump inhibitors or to their inactive ingredients
14.Known allergy to heparin or history of heparin-induced thrombocytopenia
15.Donated blood or blood products or had substantial loss of blood (more than 7 mL/kg) within 3 mo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: None;Primary end point(s): Not applicable, no primary end point is specified for this study. This is an exploratory assessment, several endpoints will be investigated (PK, PD and safety measures);Timepoint(s) of evaluation of this end point: Not applicable;<br> Main Objective: The objective of this trial is to evaluate the pharmacokinetics, pharmacodynamics (intraesophageal/intragastric pH, clinical global impressions, formulation palatability and 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<br> As this is an exploratory assessment of the pharmacokinetics, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable