Status:
COMPLETED
Phase 3/Safety & Efficacy of Esomeprazole in Infants
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research s...
Eligibility Criteria
Inclusion
- patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
- patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams
Exclusion
- patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
- patients with a history of acute life-threatening event
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00468559
Start Date
April 1 2007
End Date
June 1 2008
Last Update
June 2 2014
Active Locations (25)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Atlanta, Georgia, United States
3
Research Site
Park Ridge, Illinois, United States
4
Research Site
Louisville, Kentucky, United States