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

Phase 1

Completed

• Conditions: Endoscopically-Proven GERD; Reflux
• Interventions: Drug: esomeprazole magnesium

• Registration Number: NCT00687245
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-10
• Last Update Posted: 2008-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	esomeprazole magnesium	esomeprazole magnesium 10 mg, weight \> 20 kg
1	esomeprazole magnesium	esomeprazole magnesium 5 mg, weight 8 kg to \< 20kg
2	esomeprazole magnesium	esomeprazole magnesium 10 mg, weight 8 kg to \< 20kg
4	esomeprazole magnesium	esomeprazole magnesium 20 mg, weight \> 20 kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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