Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468728
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2007-05-01
Brief Title:
PAR-101OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea CDAD
Sponsor:
Optimer Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Optimer Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea CDAD
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This is a comparative study to investigate the safety and efficacy of PAR-101OPT-80 fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea CDAD
Detailed Description:
The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea CDAD The cure rates at end of therapy and recurrence rates will be evaluated and compared
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1011C004 | OTHER | Optimerpharma Study Number | None |