Status:
COMPLETED
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
AstraZeneca
Conditions:
Endoscopically-Proven GERD
Reflux
Eligibility:
All Genders
1-11 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00687245
Start Date
August 1 2006
End Date
May 1 2008
Last Update
June 11 2008
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