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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00687245

Purpose

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.

Condition	Intervention	Phase
Endoscopically-Proven GERD Reflux	Drug: esomeprazole magnesium	Phase I

MedlinePlus related topics: GERD

Drug Information available for: Magnesium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Safety and tolerability after a single oral dose of esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically- proven GERD. [ Time Frame: Day 1, Day 15 ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	August 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental esomeprazole magnesium 5 mg, weight 8 kg to < 20kg	Drug: esomeprazole magnesium capsules, oral, qd, one day
2: Experimental esomeprazole magnesium 10 mg, weight 8 kg to < 20kg	Drug: esomeprazole magnesium capsules, oral, qd, one day
3: Experimental esomeprazole magnesium 10 mg, weight > 20 kg	Drug: esomeprazole magnesium capsules, oral, qd, one day
4: Experimental esomeprazole magnesium 20 mg, weight > 20 kg	Drug: esomeprazole magnesium capsules, oral, qd, one day

Eligibility

Ages Eligible for Study:	1 Year to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687245

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Marta Illueca	AstraZeneca
Study Chair:	Lynne Durborow	AstraZeneca

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Tore Lind, MD, Medical Science Director Nexium and GI Established Brands )
Study ID Numbers:	D9614C00007
Study First Received:	May 28, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00687245
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

children
reflux
GERD
pediatric

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009