A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of Esomeprazole Magnesium in a Pediatric Population of 1 to 11 Year olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD

• Conditions: 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: 14.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-001157-97-Outside-EU/EEA
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 31

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified