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

NCT ID: NCT00687245

Last Updated: 2008-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-05-31

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.

Detailed Description

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Conditions

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Endoscopically-Proven GERD Reflux

Keywords

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children reflux GERD pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

esomeprazole magnesium 5 mg, weight 8 kg to \< 20kg

Group Type EXPERIMENTAL

esomeprazole magnesium

Intervention Type DRUG

capsules, oral, qd, one day

2

esomeprazole magnesium 10 mg, weight 8 kg to \< 20kg

Group Type EXPERIMENTAL

esomeprazole magnesium

Intervention Type DRUG

capsules, oral, qd, one day

3

esomeprazole magnesium 10 mg, weight \> 20 kg

Group Type EXPERIMENTAL

esomeprazole magnesium

Intervention Type DRUG

capsules, oral, qd, one day

4

esomeprazole magnesium 20 mg, weight \> 20 kg

Group Type EXPERIMENTAL

esomeprazole magnesium

Intervention Type DRUG

capsules, oral, qd, one day

Interventions

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esomeprazole magnesium

capsules, oral, qd, one day

Intervention Type DRUG

Other Intervention Names

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Nexium

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Marta Illueca

Role: STUDY_DIRECTOR

AstraZeneca

Lynne Durborow

Role: STUDY_CHAIR

AstraZeneca

References

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Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Rohss K, Sandstrom M, Taylor A, Tornoe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467.

Reference Type DERIVED
PMID: 27875488 (View on PubMed)

Other Identifiers

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D9614C00007

Identifier Type: -

Identifier Source: org_study_id