An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
|First Submitted Date ICMJE||December 15, 2003|
|First Posted Date ICMJE||December 16, 2003|
|Last Update Posted Date||February 21, 2007|
|Start Date ICMJE||September 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00074542 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease|
|Official Title ICMJE||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|
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.
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:
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Crohn's Disease|
|Intervention ICMJE||Drug: Epanova™ (Omega-3 Free Fatty Acids)|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Key Inclusion Criteria:
Key Exclusion Criteria:
|Ages||16 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada, United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00074542|
|Other Study ID Numbers ICMJE||Protocol TP0308 (EPIC-2)|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Tillotts Pharma AG|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Tillotts Pharma AG|
|Verification Date||October 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP