Gastroesophageal Reflux Disease (GERD)
Conditions
Interventions
Product Name: Rabeprazole Sodium
Product Code: E3810
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: RABEPRAZOLE SODIUM
CAS Number: 117976-90-6
Current Sponsor code: E3810
Concentrat
Sponsors
Eisai Medical Research Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females age 12 to 16 years, with a clinical diagnosis of, or symptoms of, GERD. 2. Subjects had to be able and willing to take the required number of test drug tablets. 3. The ability of the child to swallow an intact tablet had to be confirmed by the site at screening by history taking. 4. Minimum weight of 30 kg. 5. Willingness of the subject and ability to give assent to participate. 6. The subject's parent or guardian provided written informed consent. 7. Post-pubertal females were required to abstain from sexual relations during the course of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 24 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
Exclusion criteria: 1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agreed that the nature and severity of any abnormality was unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study. 2. Females who were pregnant, lactating or had a positive urine beta-human chorionic gonadotropin (hCG) laboratory result. 3. Subjects who were unwilling or unable to refrain from smoking or drinking alcohol starting from 48 hours prior to screening and dosing, through the end of the study, and/or a positive urine drug screen. 4. Subjects who were unwilling or unable to abide by the requirements of the study or who violated the prohibitions and restrictions of the study defined in the Study Protocol. 5. Any condition, which in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study. 6. Participation in another investigational drug study within 30 days prior to drug administration. 7. A subject history of drug allergies or sensitivity to proton pump inhibitors or to their inactive ingredients. 8. A subject history of clinically significant bacterial or viral infection within one month of screening. 9. Subject history of definitive acid-lowering surgery or previous esophageal or gastric surgery, with the exception of a simple closure of a perforated ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the PK profile of single and repeated doses of rabeprazole sodium in subjects 12 to 16 years of age with a diagnosis of, or symptoms of, GERD.;Secondary Objective: To collect information on the safety of single and repeated doses of rabeprazole sodium.;Primary end point(s): Mean peak plasma concentration (Cmax) Mean time to peak concentration (tmax) Mean elimination half-life (t1/2) during the apparent terminal disposition phase Mean area under the plasma concentration-time curve from time zero to time (AUC0-t) Mean area under the plasma concentration-time curve from time 0 to infinity (AUC0- 8) Accumulation factor (Rac) Average plasma concentration at steady state (Cav ss) Apparent clearance (CL/F) Apparent volume of distribution (Vz/F) ;Timepoint(s) of evaluation of this end point: Day 1 (predose, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, and 12 hours post-dose) , Days 2 (pre-dose and 24 hour post-dose), Days 3, 4 (pre-dose), and Day 5 or 7 (predose, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, and 12 hours post-dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of participants with treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: For each participant, from the date of signing of informed consent up to approximately 8 days | — |
Countries
United States
Contacts
Public ContactEisai Medical Information
Eisai Medical Research Inc.
Outcome results
None listed