NCT00228527

Esomeprazole for Treatment of GERD in Pediatric Patients

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 1 Year – 11 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Gastroesophageal Reflux Disease (GERD)
• Erosive Esophagitis
• Non-erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Esomeprazole (Nexium)

Timeline

• Start date: 2004-10-01
• Completion: 2005-10-01
• First posted: 2005-09-29
• Last updated: 2010-11-19

Locations

36 sites across 4 countries: United States, Belgium, France, Italy