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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

Conditions
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Endoscopically-Proven GERD, Reflux

Intervention / Treatment
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* Drug: esomeprazole magnesium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>esomeprazole magnesium 5 mg, weight 8 kg to < 20kg | Drug: esomeprazole magnesium<br>* capsules, oral, qd, one day<br>* Other names: Nexium;|
| Experimental: 2<br>esomeprazole magnesium 10 mg, weight 8 kg to < 20kg | Drug: esomeprazole magnesium<br>* capsules, oral, qd, one day<br>* Other names: Nexium;|
| Experimental: 3<br>esomeprazole magnesium 10 mg, weight > 20 kg | Drug: esomeprazole magnesium<br>* capsules, oral, qd, one day<br>* Other names: Nexium;|
| Experimental: 4<br>esomeprazole magnesium 20 mg, weight > 20 kg | Drug: esomeprazole magnesium<br>* capsules, oral, qd, one day<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, reflux, GERD, pediatric