NCT00074542

An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

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 Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (planned)
• Sponsor: Tillotts Pharma AG · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study.

Detailed description

Crohn's 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 Crohn's 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 Crohn's 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 Crohn's 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 Crohn's Disease who are responding to steroid induction therapy * To assess the efficacy of Epanova™ by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of Crohn's Disease related medical visits in subjects with Crohn's Disease who are responding to steroid induction therapy

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Epanova™ (Omega-3 Free Fatty Acids)

Timeline

• Start date: 2002-09-01
• Completion: 2005-01-01
• First posted: 2003-12-16
• Last updated: 2007-02-21

Locations

31 sites across 2 countries: United States, Canada