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

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ClinicalTrials.gov Identifier: NCT00687245
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Endoscopically-Proven GERD Reflux Drug: esomeprazole magnesium Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687245


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Marta Illueca AstraZeneca
Study Chair: Lynne Durborow AstraZeneca

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
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008

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
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action