Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106509
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2005-03-25
Brief Title:
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With CDifficile - Associated Diarrhea
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With CDifficile - Associated Diarrhea
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Approximately 520 patients will be entered into this study taking place throughout the US and Canada This study aims to determine if an investigational drug is safe and effective for treating symptoms of C difficile-associated diarrhea CDAD and lowering the risk of repeat episodes of CDAD The investigational drug will be evaluated in comparison to current standard antibiotic treatment so all patients will receive active medication All study related care is provided including doctor visits physical exams laboratory tests and study medication Total length of participation is approximately 6 weeks
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