NCT00687245

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

May 28, 2008

Last Update Submit

June 10, 2008

Conditions

Endoscopically-Proven GERDReflux

Keywords

childrenrefluxGERDpediatric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (4)

1

EXPERIMENTAL

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

Drug: esomeprazole magnesium

2

EXPERIMENTAL

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

Drug: esomeprazole magnesium

3

EXPERIMENTAL

esomeprazole magnesium 10 mg, weight \> 20 kg

Drug: esomeprazole magnesium

4

EXPERIMENTAL

esomeprazole magnesium 20 mg, weight \> 20 kg

Drug: esomeprazole magnesium

Interventions

esomeprazole magnesiumDRUG

capsules, oral, qd, one day

Also known as: Nexium
1234

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27875488DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marta Illueca

    AstraZeneca

    STUDY DIRECTOR

  • Lynne Durborow

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 11, 2008

Record last verified: 2008-06