Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132496
Status:
COMPLETED
Last Update Posted:
2009-12-03
First Post:
2005-08-19
Brief Title:
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
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:
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease GERD in children aged 12 to 16 years The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received based on symptom frequency and severity antacid use and quality of life QOL measures
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