The target subject population was male and female children, aged 1 to 11 years inclusive, who suffered from GERD or symptoms of GERD and were candidates for acid suppression therapy. 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: 1. Provision of signed, written informed consent from subject’s parent/guardian with assent from the subject if appropriate. 2. Subjects, both male and female, between the ages of 1 and 11 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 in the previous 6 months from diagnostic testing such as pH probe monitoring, scintigraphy or endoscopy was acceptable if the subject was symptomatic. Notes in the subject’s medical records and/or other source documentation were used to support the diagnosis. 4. Subjects were able to take solid food (eg, applesauce) and were of sufficient weight (at least 10 kg or 22 lb) to allow for an adequate volume of blood to be collected. 5. Post-pubertal female subjects must have had a negative urine pregnancy test at screening and prior to study drug administration on Days 1 and 5. 6. 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 throughout the study. Are the trial subjects under 18? yes Number of subjects for this age range: 31 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. Use of any other investigational compound or participation in another clinical trial within 28 days prior to 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, patch). 4. History or presence of gastrointestinal, hepatic, or renal disease or other condition that could have interfered with absorption, distribution, metabolism or excretion of esomeprazole. 5. Unstable diabetes mellitus or history of a seizure disorder. 6. 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. 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. Concurrent use of anti-epileptic medications phenytoin, mephenytoin, antineoplastic agents, pro-motility drugs (prokinetics), sucralfate or Warfarin. 10. Use of any drug known to affect the PK parameters of esomeprazole within 14 days prior to the first dose of study drug (Day 1). 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. Clinically significant abnormal values at screening from the laboratory measurements, physical examination, or vital signs which, in the opinion of the investigator, could have put the subject at risk when participating 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 the area under the curve (AUC) of esomeprazole after multiple oral doses of 5 mg, 10 mg, and 20 mg esomeprazole magnesium in 1 to 11 year olds, inclusive with GERD or symptoms of GERD.;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) of esomeprazole after multiple oral doses of 5 mg, 10 mg, and 20 mg esomeprazole in 1 to 11 year olds, inclusive with GERD or symptoms of GERD. • To determine AUC, AUC(0-t), Cmax, tmax, t½?z of the 5-hydroxy and sulphone metabolites of esomeprazole after multiple oral doses of 5 mg, 10 mg, and 20 mg esomeprazole magnesium in 1 to 11 year olds, inclusive with GERD or symptoms of GERD. (Note: The PK parameters of the 5-hydroxy metabolite were not determined because it could not be separated from the 3-hydroxy metabolite on the HPLC chromatogram.) • To assess the safety and tolerability of esomeprazole in 1 to 11 year olds, inclusive with GERD or symptoms of GERD. ;Primary end point(s): Pharmacokinetic: Blood samples were analyzed to determine the pharmacokinetics of esomeprazole magnesium (AUC, AUC(0-t), Cmax, tmax, t½?z, CL/F, V?z/F and Vss/F) and the pharmacokinetics of its sulphone metabolite (AUC, AUC(0-t), Cmax, tmax, t½?z) in the specified population. Safety: Safety and tolerability were assessed by means of incidence and severity of all adverse events, vital signs, laboratory parameters and physical examinations. ;Timepoint(s) of evaluation of this end point: The final dose of study drug was administered on the morning of Day 5 and PK was measured. Fourteen or 15 days after Day 5, all subjects/parents/guardians received a follow-up telephone call from the CRC. Information was collected regarding any AE (adverse event) resolution and/or potential SAEs (serious adverse events) that occurre | — |
Countries
United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed