Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endoscopically-Proven GERD; Reflux
Intervention: esomeprazole magnesium (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Marta Illueca, Study Director, Affiliation: AstraZeneca
Lynne Durborow, Study Chair, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Other, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: 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.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. Safety and tolerability after a single oral dose of esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically- proven GERD.
Eligibility
Minimum age: 1 Year.
Maximum age: 11 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: August 2006
Ending date: May 2008
Last updated: June 10, 2008
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