Esomeprazole for Treatment of GERD in Pediatric Patients
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.
Gastroesophageal Reflux Disease (GERD)
Drug: Esomeprazole (Nexium)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.|
- 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
|Study Start Date:||October 2004|
|Study Completion Date:||October 2005|
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