Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063830
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2003-07-07
Brief Title:
ISIS 2302-CS27 A 6-Week Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen ISIS 2302 in Patients With Mild to Moderate Active Ulcerative Colitis
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
ISIS 2302-CS27 Phase 2 Double-Blinded Controlled Study of Four Dosing Regimens of Alicaforsen ISIS 2302 Enema an Antisense Inhibitor of ICAM-1 for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2007-10
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 multi-center trial in the US and Europe to test the safety efficacy and tolerability of alicaforsen ISIS 2302 a new type of drug called an antisense drug in patients with mild to moderate active Ulcerative Colitis UC Alicaforsen is designed to reduce the production of a specific protein called ICAM-1 a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis The ISIS 2302-CS27 study will compare four dosing regimens and determine the minimum effective dose of alicaforsen enema in UC patients over six weeks as compared to a placebo enema The probability of receiving active formulation is 41 The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6
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