Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074542
Status:
COMPLETED
Last Update Posted:
2007-02-21
First Post:
2003-12-15
Brief Title:
An Efficacy and Safety Study of Omega-3 Free Fatty Acids Epanova for the Maintenance of Symptomatic Remission in Subjects With Crohns Disease
Sponsor:
Tillotts Pharma AG
Organization:
Tillotts Pharma AG
Study Overview
Official Title:
A Phase III Randomized Placebo-Controlled Double-Blind Parallel Group Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids Epanova for the Maintenance of Symptomatic Remission in Subjects With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if Epanova is able to maintain the symptomatic remission in subjects with Crohns Disease who are responding to steroid induction therapy
Patient safety and quality of life will also be monitored throughout the study
Patient safety and quality of life will also be monitored throughout the study
Detailed Description:
Crohns disease is a chronic inflammatory disorder that frequently involves the colon and small bowel Patients commonly experience abdominal pain diarrhea and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment
Currently available therapeutic options for the maintenance of remission in Crohns disease are inadequate Patients quality of life is often severely diminished A clear need exists for well-tolerated drugs that can reliably reduce the risk of a disease relapse
In recent years considerable attention has been focused on dietary marine fish oils as a means of treating several chronic inflammatory disorders including Crohns disease Fish oils have been found to reduce the inflammation and the severity of lesions in animal models of inflammatory bowel disease
Commercially available fish oils are supplied as fatty acid triglycerides or ethyl esters and are often associated with unpleasant side effects such as nausea flatulence diarrhea and belching These adverse effects limit administration of high doses of these preparations Several studies have demonstrated the superior absorption across intestinal membranes of free fatty acids in comparison with triglycerides and ethyl esters Epanova is being developed as a well-tolerated means of delivering a high concentration of marine fish oils as free fatty acids Additionally the gelatin coating of the capsules consists of a permeable polymer that results in a delayed release of the active compounds thus reducing the frequency of adverse events
The objectives of this clinical trial are as follows
Primary Objective
To assess the ability of Epanova to maintain symptomatic remission in subjects with Crohns Disease who are responding to steroid induction therapy
Secondary objectives
To assess the safety and tolerability of Epanova
To assess the ability of Epanova to maintain the quality of life in subjects with Crohns Disease who are responding to steroid induction therapy
To assess the efficacy of Epanova by Crohns Disease Activity Index CDAI Investigator and Subject Global Ratings employment status and use of Crohns Disease related medical visits in subjects with Crohns Disease who are responding to steroid induction therapy
Currently available therapeutic options for the maintenance of remission in Crohns disease are inadequate Patients quality of life is often severely diminished A clear need exists for well-tolerated drugs that can reliably reduce the risk of a disease relapse
In recent years considerable attention has been focused on dietary marine fish oils as a means of treating several chronic inflammatory disorders including Crohns disease Fish oils have been found to reduce the inflammation and the severity of lesions in animal models of inflammatory bowel disease
Commercially available fish oils are supplied as fatty acid triglycerides or ethyl esters and are often associated with unpleasant side effects such as nausea flatulence diarrhea and belching These adverse effects limit administration of high doses of these preparations Several studies have demonstrated the superior absorption across intestinal membranes of free fatty acids in comparison with triglycerides and ethyl esters Epanova is being developed as a well-tolerated means of delivering a high concentration of marine fish oils as free fatty acids Additionally the gelatin coating of the capsules consists of a permeable polymer that results in a delayed release of the active compounds thus reducing the frequency of adverse events
The objectives of this clinical trial are as follows
Primary Objective
To assess the ability of Epanova to maintain symptomatic remission in subjects with Crohns Disease who are responding to steroid induction therapy
Secondary objectives
To assess the safety and tolerability of Epanova
To assess the ability of Epanova to maintain the quality of life in subjects with Crohns Disease who are responding to steroid induction therapy
To assess the efficacy of Epanova by Crohns Disease Activity Index CDAI Investigator and Subject Global Ratings employment status and use of Crohns Disease related medical visits in subjects with Crohns Disease who are responding to steroid induction therapy
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