Crohn's DiseasePhase 3NCT00074542
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 3 study testing Epanova™ (Omega-3 Free Fatty Acids) in people with Crohn's Disease, run by Tillotts Pharma AG at 31 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Epanova™ (Omega-3 Free Fatty Acids)
- How many people
- 364 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Sep 2002to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
Canada21 sites
Health Sciences Centre
Calgary, Alberta, T1Y 6J4
Royal Alexandra Hospital
Edmonton, Alberta, T5H 4B9
University of Alberta
Edmonton, Alberta, T6G 2C8
Victoria General Hospital
Halifax, Nova Scotia, B3H 1V7
London Health Sciences Centre (South Street Campus)
London, Ontario, N6A 4G5
London Health Sciences Centre (University Campus)
London, Ontario, N6A 5A5
CHUQ - Pavillon St-François d'Assise
Montreal, Quebec, G1L 3L5
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, K1Y 4E9
CHUQ-Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
Hôpital St-Sacrement
Québec, Quebec, G1S 4L8
Sunnybrook & Women's College HSC
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L5
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
United States10 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342-5006
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-7032
Northwestern University Medical School
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Long Island Clinical Research Associates
Great Neck, New York, 11021
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503
University of Louisville, Department of Surgery
Louisville, Kentucky, 40292
Mayo Clinic
Rochester, Minnesota, 55905
Carle Clinic Association
Urbana, Illinois, 61801
About this study
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
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.
Read the 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
- Conditions
- Crohn's Disease
- Being tested
- Epanova™ (Omega-3 Free Fatty Acids)
- Keywords
- Crohn's, colon, small bowel, inflammation, steroid therapy, free fatty acids
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epanova™ (Omega-3 Free Fatty Acids)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2003 (estimated)
- Study startSep 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 364 participants
Sponsor and investigators
- Lead sponsor
- Tillotts Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074542
- Sponsor's protocol ID
- Protocol TP0308 (EPIC-2)
- Status last verified
- Oct 2005
- First submitted
- 15 Dec 2003
- Last updated
- 21 Feb 2007
- Results posted
- No
Publications
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.
PubMed 8628335Feagan 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.
PubMed 18398081
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00074542
- Acronym / sponsor ID
- Protocol TP0308 (EPIC-2)
- Conditions
- Crohn's Disease
- Keywords
- Crohn's, colon, small bowel, inflammation, steroid therapy, free fatty acids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Jan 2005
- First posted
- 16 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epanova™ (Omega-3 Free Fatty Acids) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
- Background: PubMed 8628335Belluzzi 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.
- Derived from this study: PubMed 18398081Feagan 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.
- Sponsor's WebsiteLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epanova™ (Omega-3 Free Fatty Acids) in people with Crohn's Disease, run by Tillotts Pharma AG at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074542, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2007.