An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
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.
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
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Crohn's Disease
Intervention
Epanova™ (Omega-3 Free Fatty Acids)
Location
Atlanta Gastroenterology Associates
Atlanta
Georgia
United States
30342-5006
Status
Completed
Source
Tillotts Pharma AG
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00074542
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:52:11-0400
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Medical and Biotech [MESH] Definitions
Fatty Acids, Omega-6
FATTY ACIDS which have the first unsaturated bond in the sixth position from the omega carbon. A typical American diet tends to contain substantially more omega-6 than OMEGA-3 FATTY ACIDS.
Fatty Acids, Omega-3
A group of fatty acids, often of marine origin, which have the first unsaturated bond in the third position from the omega carbon. These fatty acids are believed to reduce serum triglycerides, prevent insulin resistance, improve lipid profile, prolong bleeding times, reduce platelet counts, and decrease platelet adhesiveness.
Fatty Acid Transport Proteins
A broad category of membrane transport proteins that specifically transport FREE FATTY ACIDS across cellular membranes. They play an important role in LIPID METABOLISM in CELLS that utilize free fatty acids as an energy source.
Oleic Acids
A group of fatty acids that contain 18 carbon atoms and a double bond at the omega 9 carbon.
Fatty Acids, Nonesterified
FATTY ACIDS found in the plasma that are complexed with SERUM ALBUMIN for transport. These fatty acids are not in glycerol ester form.
