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
1 other identifier
interventional
364
2 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2002
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 15, 2003
CompletedFirst Posted
Study publicly available on registry
December 16, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFebruary 21, 2007
October 1, 2005
December 15, 2003
February 20, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years of age or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342-5006, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
University of Louisville, Department of Surgery
Louisville, Kentucky, 40292, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-7032, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Health Sciences Centre
Calgary, Alberta, T1Y 6J4, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L5, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Victoria General Hospital
Halifax, Nova Scotia, B3H 1V7, Canada
London Health Sciences Centre (South Street Campus)
London, Ontario, N6A 4G5, Canada
London Health Sciences Centre (University Campus)
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook & Women's College HSC
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
CHUQ - Pavillon St-François d'Assise
Montreal, Quebec, G1L 3L5, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHUQ-Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6, Canada
Hôpital St-Sacrement
Québec, Quebec, G1S 4L8, Canada
Related Publications (2)
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. doi: 10.1056/NEJM199606133342401.
PMID: 8628335BACKGROUNDFeagan BG, Sandborn WJ, Mittmann U, Bar-Meir S, D'Haens G, Bradette M, Cohen A, Dallaire C, Ponich TP, McDonald JW, Hebuterne X, Pare P, Klvana P, Niv Y, Ardizzone S, Alexeeva O, Rostom A, Kiudelis G, Spleiss J, Gilgen D, Vandervoort MK, Wong CJ, Zou GY, Donner A, Rutgeerts P. Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials. JAMA. 2008 Apr 9;299(14):1690-7. doi: 10.1001/jama.299.14.1690.
PMID: 18398081DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 15, 2003
First Posted
December 16, 2003
Study Start
September 1, 2002
Study Completion
January 1, 2005
Last Updated
February 21, 2007
Record last verified: 2005-10