Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038766
Status:
TERMINATED
Last Update Posted:
2012-08-23
First Post:
2002-06-05
Brief Title:
CNI-1493 for Treatment of Moderate to Severe Crohns Disease
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohns Disease
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll into study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CD02
Brief Summary:
The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohns Disease
Detailed Description:
Crohns disease CD is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain weight loss gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs Current therapy for active Crohns disease consists of symptomatic treatment nutritional therapy salicylates and immunosuppressants or surgical management
Tumor necrosis factor a TNF-a plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD van Deventer 1997 Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD Braegger et al 1992 CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis A monoclonal antibody to TNF infliximab is now approved for treatment of CD but not all patients respond and many who do respond eventually become refractory to this treatment as well
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines including TNF Because it blocks production of multiple inflammatory mediators it may be more active than products targeted to a specific cytokine In addition as it is not a biologic it should not cause hypersensitivity reactions or induce formation of antibodies
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohns Disease in a placebo controlled setting
Tumor necrosis factor a TNF-a plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD van Deventer 1997 Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD Braegger et al 1992 CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis A monoclonal antibody to TNF infliximab is now approved for treatment of CD but not all patients respond and many who do respond eventually become refractory to this treatment as well
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines including TNF Because it blocks production of multiple inflammatory mediators it may be more active than products targeted to a specific cytokine In addition as it is not a biologic it should not cause hypersensitivity reactions or induce formation of antibodies
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohns Disease in a placebo controlled setting
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