Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468559
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2007-04-30
Brief Title:
Phase 3Safety Efficacy of Esomeprazole in Infants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Parallel-group Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux GERD in Infants Aged 1 to 11 Months Inclusive
Status:
COMPLETED
Status Verified Date:
2014-04
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 purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease GERD This research study consists of a screening open-label and double-blind treatment withdrawal phase The screening phase ensures the patient eligibility No study medication is dispensed during the screening phase During the open-label phase patients are administered esomeprazole 25mg 50mg or 100mg based on hisher weight During the double-blind phase the patients are administered either hisher open-label dose or placebo Double-blind means neither the physician parent or patient will know if patient is taking esomeprazole or placebo The patient will have an equal chance of receiving esomeprazole or placebo
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