Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Endoscopically-Proven GERD

Reflux

Treatments

Drug: esomeprazole magnesium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00687245

D9614C00007

Details and patient eligibility

About

The purpose of this study is 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.

Enrollment

40 patients

Sex

All

Ages

1 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be able to take solid or bland food (eg, applesauce).
Patients must weigh at least 8 kg and at the investigator's discretion be able to undergo extraction of an adequate volume of blood.
The patient's weight for height percentile should be less than the 90th percentile and/or the BMI must be between the 5th and 85th percentile for age.
Patients must be diagnosed with endoscopically-proven GERD

Exclusion criteria

Use of any other investigational compound or participation in another clinical trial within 28 days prior to the screening visit.
History or presence of gastrointestinal, hepatic or renal disease or other conditions that could interfere with absorption, distribution, metabolism or excretion of esomeprazole.
Unstable diabetes mellitus or history of seizure disorder.
Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could compromise the patient's safety or successful participation in the study.