Pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD. MedDRA version: 14.1 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
AstraZeneca LP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, patients had to fulfill all of the following criteria: 1. Provide signed, written informed consent from patient’s parent/guardian with assent from the patient, if appropriate 2. Patients were between the ages of 1 and 11, inclusive, and able to take solid or bland food (eg, applesauce) 3. Patients weighed at least 8 kg and, at the investigator’s discretion, were able to undergo extraction of an adequate volume of blood 4. The patient’s weight for height percentile should have been less than the 90th percentile or the body mass index (BMI) must have been between the 5th and 95th percentile for age. 5. Patients were diagnosed with endoscopically proven GERD by the investigator during the screening period (Visit 1). In addition, patients with a previous (within 42 days of Visit 1) endoscopic diagnosis of GERD induced esophagitis were not required to have another endoscopy to be enrolled into this study. Patients weighing =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. Use of any other investigational compound or participation in another clinical trial within 28 days before the screening visit. 2. History or presence of gastrointestinal (GI), hepatic, or renal disease, or other conditions that could interfere with absorption, distribution, metabolism, or excretion of esomeprazole. 3. Unstable diabetes mellitus or history of seizure disorder. 4. Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could have compromised the patient’s safety or successful participation in the study. 5. Patients with the following diseases/conditions:active GI bleed, active peptic ulcer disease, eosinophilic gastroenteritis, allergic gastroenteropathies, inflammatory bowel disease, bleeding disorders, seizure disorders, acute pancreatitis, metabolic diseases, or meningitis. Patients with a past history (before study enrollment) of erosive esophagitis (EE), duodenal ulcers (DU), gastric ulcers (GU) and/or Helicobacter pylori (H. pylori) infection were eligible for this study if they satisfied other inclusion/exclusion criteria. Patients with active H. pylori infection may have been enrolled into the study provided anti Helicobacter antibiotic therapy was withheld until after the study was completed. This decision was made at the investigator’s discretion and with agreement from the patient’s parent/guardian. 6. Female patients who were taking hormonal contraceptives for medical reasons. 7. Patients who must have remained on any of the following concomitant medications during the course of the study: bismuth containing products, barbiturates, anti convulsants, anti coagulants, narcotics, anti neoplastic agents, H2RAs, sucralfate, anti emetics, systemic steroids (oral and intravenous), pro motility drugs (eg, cisapride, metoclopramide, domperidone) or macrolide antibiotics such as erythromycin. Use of topical erythromycin was permissible. Occasional doses of nonsteroidal anti inflammatory drugs or salicylates (?3 days) to treat acute conditions were permissible. 8. The patient’s endoscopic findings must have had no evidence of advanced esophageal lesions due to GERD or other severe upper GI tract pathology (eg, Barrett’s, stricture, neoplasm). 9. Patients with a history or a current need for resectional or reconstructive surgery of the GI tract (eg, esophagus, stomach, duodenum, jejunum, or colon) were excluded except for those who required surgery for a diagnosis of esophageal atresia (any variant) or pyloric stenosis. 10. History of multiple drug allergies unless otherwise agreed by AstraZeneca and the investigator. 11. Hypersensitivity, allergy, or intolerance to esomeprazole, any ingredient in its formulation or any drug with a similar chemical structure to esomeprazole. 12. Current use of anti epileptic medications phenytoin, mephenytoin, antineoplastic agents, pro motility drugs (prokinetics), sucralfate, or warfarin. 13. Use of any drug known to affect the pharmacokinetic parameters of esomeprazole within 14 days before administration of study drug on Day 1. These drugs included, but were not limited to, enzyme inducers such as phenobarbital, carbamazepine, rifampin, and St. John’s Wort, or enzyme inhibitors such as clarithromycin, erythromycin, selective serotonin re uptake inhibitors, cimetidine, itraconazole, protease inhibitors, and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study was to determine the area under the plasma concentration time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg, or 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically proven GERD.;Secondary Objective: The secondary objectives were as follows: 1. To determine the area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC(0 t)), maximum plasma concentration (Cmax), time to reach Cmax (tmax), terminal half life (t1/2?z), apparent oral clearance (CL/F), and apparent volume of distribution during terminal phase (V?z/F) of esomeprazole after single oral doses of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD. 2. To determine AUC, AUC(0 t), Cmax, tmax, and t1/2?z of the 5-hydroxy and sulphone metabolites of esomeprazole after a single oral dose of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically proven GERD. 3. To assess the safety and tolerability of esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD. ;Timepoint(s) of evaluation of this end point: During the course of the study. Treatment one day. Safety follow-up up to 2 weeks post dosing.;Primary end point(s): Variables - Pharmacokinetic Blood samples were analyzed to determine the pharmacokinetics of esomeprazole (AUC, AUC(0 t), Cmax, tmax, t1/2?z, CL/F, V?z/F) and its 5 hydroxy and sulphone metabolites (AUC, AUC(0 t), Cmax, tmax, t1/2?z). - Safety Safety and tolerability were evaluated from the incidence and severity of all adverse events and the assessment of laboratory parameters, vital signs measurements, and physical examination findings | — |
Countries
United States
Contacts
Public ContactInformation center
AstraZeneca
Outcome results
None listed