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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00687245
First received: May 28, 2008
Last updated: June 10, 2008
Last verified: June 2008
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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

  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

No publications provided

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

Keywords provided by AstraZeneca:
children
reflux
GERD
pediatric

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013