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

This study has been completed.
Sponsor:
Information provided by:
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT00074542
First received: December 15, 2003
Last updated: February 20, 2007
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Epanova™ (Omega-3 Free Fatty Acids)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Tillotts Pharma AG:

Estimated Enrollment: 364
Study Start Date: September 2002
Estimated Study Completion Date: January 2005
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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074542

  Hide Study Locations
Locations
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342-5006
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Kentucky
University of Louisville, Department of Surgery
Louisville, Kentucky, United States, 40292
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, United States, 68503
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Canada, Alberta
Health Sciences Centre
Calgary, Alberta, Canada, T1Y 6J4
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L5
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Victoria General Hospital
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London Health Sciences Centre (University Campus)
London, Ontario, Canada, N6A 5A5
London Health Sciences Centre (South Street Campus)
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, Canada, K1Y 4E9
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook & Women's College HSC
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUQ - Pavillon St-François d'Assise
Montreal, Quebec, Canada, G1L 3L5
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hôpital Saint-Luc
Montreal, Quebec, Canada, H2X 3J4
CHUQ-Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
Canada
Hôpital St-Sacrement
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Tillotts Pharma AG
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00074542     History of Changes
Other Study ID Numbers: Protocol TP0308 (EPIC-2)
Study First Received: December 15, 2003
Last Updated: February 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Tillotts Pharma AG:
Crohn's
colon
small bowel
inflammation
steroid therapy
free fatty acids

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014