Completed

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

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What is being tested

Data Collection

Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2002
See protocol details

Summary

Principal SponsorTillotts Pharma AG
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2002

Actual date on which the first participant was enrolled.

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

Official TitleA 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 
NCT00074542
Principal SponsorTillotts Pharma AG
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

364 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 31 locations

Suspended

Atlanta Gastroenterology Associates

Atlanta, United StatesSee the location
Suspended

Northwestern University Medical School

Chicago, United States
Suspended

University of Chicago Medical Center

Chicago, United States
Suspended

Carle Clinic Association

Urbana, United States
Completed31 Study Centers