Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242281
Status:
COMPLETED
Last Update Posted:
2006-10-25
First Post:
2005-10-18
Brief Title:
APC-111 MP Tablet Once a Day vsPenicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
Sponsor:
Advancis Pharmaceutical Corporation
Organization:
Advancis Pharmaceutical Corporation
Study Overview
Official Title:
A Phase III Multicenter Study to Evaluate the SafetyEfficacy of APC-111 MP Tablet QD vs Penicillin VK QID Both for 10 Days Treatment of Pharyngitis Secondary to SPyogenes in AdolescentsAdults
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 evaluate the efficacy of APC 111 MP Tablet 775 mg tablet given orally POonce daily QD for 10 days compared to that of Penicillin VK 250 mg PO four times daily QID for 10 days in terms of bacteriological outcome at the Test-of-Cure TOC Visit Day 14-18 in the eligible Per-Protocol bacteriological PPb population
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