Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228527
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2005-09-27
Brief Title:
Esomeprazole for Treatment of GERD in Pediatric Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None