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

Reflux Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687245
• Other study ID #: D9614C00007
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: June 10, 2008
• Start date: August 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Endoscopically-Proven GERD
• Gastroesophageal Reflux
• Reflux

Intervention

Drug:
• esomeprazole magnesium
capsules, oral, qd, one day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The AUC(0-t), Cmax, tmax, and apparent volume of distribution during terminal phase (V?z/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	No
Secondary	AUC, AUC(0-t), Cmax, tmax, t1/2?z 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	No
Secondary	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	Yes