Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00932802
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2009-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Greatest International Antiinfective Trial With Avelox
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
GIANT - Greatest International Antiinfective Trial With Avelox®
Status:
COMPLETED
Status Verified Date:
2012-11
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:
GIANT
Brief Summary:
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12206 | OTHER | Company Internal | View | |
| 12214 | OTHER | Company Internal | View | |
| 12234 | OTHER | Company Internal | View | |
| 12213 | OTHER | Company Internal | View | |
| 12212 | OTHER | Company Internal | View | |
| 12216 | OTHER | Company Internal | View | |
| 12220 | OTHER | Company Internal | View | |
| 12219 | OTHER | Company Internal | View | |
| 12217 | OTHER | Company Internal | View | |
| 12225 | OTHER | Company Internal | View | |
| 12223 | OTHER | Company Internal | View | |
| 12229 | OTHER | Company Internal | View | |
| 12221 | OTHER | Company Internal | View | |
| 12218 | OTHER | Company Internal | View | |
| 12222 | OTHER | Company Internal | View | |
| 12230 | OTHER | Company Internal | View | |
| 12211 | OTHER | Company Internal | View | |
| 12227 | OTHER | Company Internal | View | |
| 12228 | OTHER | Company Internal | View | |
| 12226 | OTHER | Company Internal | View | |
| 12235 | OTHER | Company Internal | View | |
| 12233 | OTHER | Company Internal | View | |
| 12224 | OTHER | Company Internal | View | |
| 12215 | OTHER | Company Internal | View | |
| 12231 | OTHER | Company Internal | View | |
| 12232 | OTHER | Company Internal | View | |
| AX0401 | OTHER | Company Internal | View | |
| 11828 | OTHER | Company Internal | View |