12- to 17-year-olds inclusive with GERD or symptoms of GERD. MedDRA version: 14.1 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, all of the following criteria needed to be fulfilled: 1. Provision of signed written informed consent from subject’s parent/guardian with assent from the subject. 2. Subjects, both male and female, between the ages of 12 and 17 inclusive. 3. Subjects must have had a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, symptoms identified during review of systems, laboratory test results, or information from diagnostic testing. Notes in the subject’s medical record and/or other source documentation were used to support the diagnosis. 4. Females must have had a negative pregnancy test at screening and prior to dosing on Day 1 and Day 8. 5. Females of childbearing potential must have used a reliable form of contraception, other than systemic, hormonal contraceptives, if sexually active. 6. Subjects were able to swallow capsules. 7. Subjects were able to tolerate discontinuation of their PPI therapy for 7 days and/or H2RA therapy for 3 days prior to the first dose of study drug and during the study. 8. Subjects were willing to communicate with the investigator and comply with all study procedures. Are the trial subjects under 18? yes Number of subjects for this age range: 16 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: Any of the following was regarded as a criterion for exclusion from the study: 1. Subjects who had received an experimental compound or participated in another clinical trial within 28 days preceding the screening visit. 2. Female subjects who were pregnant, wished to become pregnant during the study or were lactating. 3. Female subjects who were taking a systemic, hormonal contraceptive (eg, oral, parenteral, or transdermal). 4. Subjects who had a history or presence of GI, hepatic, or renal disease or other condition that could have interfered with absorption, distribution, metabolism or excretion of esomeprazole. 5. Subjects who had a seizure disorder or unstable diabetes mellitus. 6. Subjects who had any acute or chronic illness or a medical history, which, in the opinion of the investigator, could have compromised the subject’s safety or successful participation in the study. 7. Subjects who had a history of multiple drug allergies unless otherwise agreed by AstraZeneca and the investigator. 8. Hypersensitivity, allergy or intolerance to esomeprazole, any ingredient in its formulation or any drug with a similar chemical structure to esomeprazole. 9. Subjects who were currently taking anti-epileptic medications, phenytoin, mephenytoin, antineoplastic agents, pro-motility drugs (prokinetics), sucralfate or Warfarin. 10. Subjects who had taken any drug known to affect the PK of esomeprazole within 14 days prior to screening. These drugs included, but were not limited to, enzyme inducers such as phenobarbital, carbamazepine, rifampicin and St. John’s Wort, or enzyme inhibitors such as clarithromycin, erythromycin, SSRIs, cimetidine, itraconazole, protease inhibitors and ketaconazole. 11. Subjects who had a history of drug abuse or alcohol dependence or current abuse. 12. Subjects who were unwilling to take the study drug according to dosing instructions. 13. Subjects who had clinically significant abnormal values at screening from laboratory measurements, physical examination or vital signs which, in the opinion of the investigator, may have either put the subject at risk when participating in the study, or affected the subject’s ability to participate in the study, other than those directly related to some concurrent and stable disease or if the values from laboratory measurements were both unexplained and potentially significant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine AUC after single and repeated (multiple) oral doses of 20 mg and 40 mg esomeprazole magnesium in 12- to 17-year-olds inclusive with GERD or symptoms of GERD. ;Timepoint(s) of evaluation of this end point: PK measurements on dosing day 1 and final dosing day 8. Safety up to 2 weeks post last dosing.;Secondary Objective: Secondary Objectives: To determine the AUC(0-t), Cmax, tmax, t½?z, apparent oral clearance (CL/F), apparent volume of distribution during terminal phase (V?z /F), and apparent volume of distribution at steady state (Vss/F) after single and repeated (multiple) oral doses of 20 mg and 40 mg esomeprazole magnesium in 12- to 17-year-olds inclusive with GERD or symptoms of GERD. To assess the safety and tolerability of esomeprazole magnesium in 12- to 17-year-olds with GERD or symptoms of GERD. ;Primary end point(s): Variables - Pharmacokinetic Blood samples were analyzed to determine the PK (AUC, AUC(0-t), Cmax, tmax, t½?z, CL/F, V?z /F, and Vss /F) of esomeprazole magnesium in the specified population. The AUC was the primary variable. - Safety Safety and tolerability were assessed by means of incidence and severity of adverse events (AEs), vital signs, laboratory parameters and physical examinations. | — |
Countries
United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed