Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373334
Status:
COMPLETED
Last Update Posted:
2009-11-18
First Post:
2006-09-07
Brief Title:
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease GERD
Sponsor:
Braintree Laboratories
Organization:
Braintree Laboratories
Study Overview
Official Title:
A Double-Blind Randomized Parallel Multicenter Study of Axid Nizatidine Oral Solution in the Treatment of Gastroesophageal Reflux Disease GERD Symptoms in Infants Age 30 Days-1 Year
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 objective of this study is to evaluate the efficacy acceptability and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease GERD in infants age 30 days up to 1 year
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