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 gastroesophageal reflux disease (GERD) and diagnosed by endoscopy. To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe. To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Wilmington, Delaware, United States
Research Site
Orlando, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.
The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive.
The secondary objectives include:
- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
- Assessment of changes from baseline in Physician's Global Assessment
- Assessment of endoscopic healing of erosive esophagitis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Park Ridge, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Jackson, Mississippi, United States
...and 26 more locations