Status:
COMPLETED
Esomeprazole for Treatment of GERD in Pediatric Patients
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease (GERD)
Erosive Esophagitis
Eligibility:
All Genders
1-11 years
Phase:
PHASE4
Brief Summary
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastr...
Eligibility Criteria
Inclusion
- Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
- Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
- Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.
Exclusion
- Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.
- Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
- Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00228527
Start Date
October 1 2004
End Date
October 1 2005
Last Update
November 19 2010
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Mobile, Alabama, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Wilmington, Delaware, United States
4
Research Site
Orlando, Florida, United States