Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063414
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2003-06-25
Brief Title:
ISIS 2302-CS22 A 6-Week Active-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-CS22 Phase II Double-Blinded Active-Controlled Study of Alicaforsen ISIS 2302 Enema an Antisense Inhibitor of ICAM-1 for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis Left-Sided Colitis or Pancolitis With Left Sided Disease Flare
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 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-CS22 study will examine the effects of one of two dosages of alicaforsen delivered by enema over a six-week period as compared to an active control mesalamine enema The probability of receiving the alicaforsen formulation is 21 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