Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097422
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2004-11-23
Brief Title:
OPT-80 in 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:
An Open-Label Dose Ranging Randomized Clinical Evaluation of OPT-80 in Patients 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD
Detailed Description:
This is a dose-finding study to select a safe and efficacious dose of OPT-80 Patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated
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 |
|---|---|---|---|
| OPT-80 Phase 2A | OTHER | Optimerpharma Study Number | None |