Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 9:47 AM
Study NCT ID:
NCT00373334
Status:
COMPLETED
Last Update Posted:
2009-11-18
First Post:
2006-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
Sponsor:
Braintree Laboratories
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: