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

Crohn's Disease Clinical Trial

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 Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074542
• Other study ID #: Protocol TP0308 (EPIC-2)
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2003
• Last updated: February 20, 2007
• Start date: September 2002
• Est. completion date: January 2005

Study information

• Verified date: October 2005
• Source: Tillotts Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Key Inclusion Criteria:

• symptomatic active Crohn's disease (requiring a 16-week course of induction steroid therapy at a starting dose of prednisone 40 mg or budesonide 9 mg daily)

• respond to induction therapy (CDAI<150) following 8 weeks of steroid tapering regimen to prednisone 20 mg or budesonide 6 mg daily

• Crohn's disease of at least 3 months duration

• 16 years of age or older

Key Exclusion Criteria:

• intolerance of omega-3 free fatty acid (FFA)

• intolerance of both prednisone and budesonide

• ongoing therapy for Crohn's disease with: 5-ASA compounds, immune modifiers, systemic antibiotics, tube feeding

• received in the past 3 months: systemic steroid therapy (other than study prednisone or budesonide induction therapy), azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products, preparations containing omega-3 fatty acids

• received in the past 6 months: biologicals e.g. enbrel, infliximab, monoclonal antibody, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products

• chronic narcotic analgesics for pain control

• short bowel syndrome, ostomy or need for bowel surgery for Crohn's disease, bowel obstruction or resection in the past 3 months

• malignancy, clinically significant impairment or conditions which could interfere with the evaluation of the trial medication

• clinically relevant hematology, liver and renal function laboratory tests

• known allergy to fish or fish products

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Epanova™ (Omega-3 Free Fatty Acids)

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Victoria General Hospital	Halifax	Nova Scotia
Canada	London Health Sciences Centre (South Street Campus)	London	Ontario
Canada	London Health Sciences Centre (University Campus)	London	Ontario
Canada	CHUQ - Pavillon St-François d'Assise	Montreal	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Hôpital Saint-Luc	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	The Ottawa Hospital (Civic Campus)	Ottawa	Ontario
Canada	Hôpital St-Sacrement	Quebec
Canada	CHUQ-Hôtel-Dieu de Québec	Québec	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook & Women's College HSC	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University Medical School	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Gastroenterology Specialties, P.C.	Lincoln	Nebraska
United States	University of Louisville, Department of Surgery	Louisville	Kentucky
United States	Mayo Clinic	Rochester	Minnesota
United States	Carle Clinic Association	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Tillotts Pharma AG

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Belluzzi A, Brignola C, Campieri M, Pera A, Boschi S, Miglioli M. Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease. N Engl J Med. 1996 Jun 13;334(24):1557-60. — View Citation

External Links

•   Sponsor's Website