Endoscopically-Proven GERD, Reflux
Conditions
Keywords
children, reflux, GERD, pediatric
Brief summary
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.
Interventions
capsules, oral, qd, one day
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) 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. | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| The AUC(0-t), Cmax, tmax, and apparent volume of distribution during terminal phase (Vλz/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. | Day 1 |
| AUC, AUC(0-t), Cmax, tmax, t1/2λz 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. | Day 1 |
| Safety and tolerability after a single oral dose of esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically- proven GERD. | Day 1, Day 15 |
Outcome results
None listed