Ignite Creation Date:
2024-05-05 @ 10:47 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189487
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2010-08-16
Brief Title:
The Study of Unasyn-S 12gDay for Community Acquired Pneumonia CAP
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Unblinded Non-Comparative Study Of Unasyn-S 12 GDay Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Unasyn-S 12gday 3 g four times a day is the commonly used dosage depending on the severity for US EU China Taiwan and Korea for over 20 years however Unasyn-S 12gday has not yet been approved in Japan The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodiumsulbactam sodium 12gday 3 g four times a day IV
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