Status:
COMPLETED
An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Lead Sponsor:
Tillotts Pharma AG
Conditions:
Crohn's Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 qual...
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 qual...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00074542
Start Date
September 1 2002
End Date
January 1 2005
Last Update
February 21 2007
Active Locations (31)
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1
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342-5006
2
Northwestern University Medical School
Chicago, Illinois, United States, 60611
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Carle Clinic Association
Urbana, Illinois, United States, 61801