Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219414
Status:
COMPLETED
Last Update Posted:
2007-09-27
First Post:
2005-09-19
Brief Title:
Study for the Treatment of Ulcerative Colitis With Adacolumn Companion to US Study 512-04-205
Sponsor:
Otsuka Frankfurt Research Institute GmbH
Organization:
Otsuka Frankfurt Research Institute GmbH
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-09
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:
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis
Detailed Description:
Study Type Interventional Study Design Treatment Randomized Double-Blind Placebo Control Parallel Assignment SafetyEfficacy Study
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