Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.
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 of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.|
- To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
- 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
- To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
- - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
- - Assessment of changes from baseline in Physician Global Assessment.
|Study Start Date:||February 2004|
|Study Completion Date:||April 2005|
Show 40 Study Locations
|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|