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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014