Completed

Epanova™ Free Fatty Acids for Symptomatic Remission Maintenance in Crohn's Disease

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What is being tested

Data Collection

Who is being recruted

Crohn Disease+6

+ Digestive System Diseases

+ Gastroenteritis

Over 16 Years
+10 Eligibility Criteria
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 27, 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 long-term condition that causes inflammation in the digestive system, leading to symptoms like abdominal pain, diarrhea, and fatigue. Current treatments for maintaining remission in Crohn's disease are not sufficient, often leaving patients with a poor quality of life. This study focuses on a drug called Epanova™, a form of marine fish oil, which has shown potential in reducing inflammation in similar conditions. The goal of this research is to evaluate if Epanova™ can effectively maintain symptomatic remission in Crohn's disease patients who respond to steroid induction therapy. During this trial, participants who respond to steroid induction therapy will be given either Epanova™ or a placebo. Epanova™ is designed to be well-tolerated and to deliver a high concentration of marine fish oils. The study will assess the safety and tolerability of Epanova™, its ability to maintain quality of life, and its effectiveness in reducing disease activity. The study also considers factors like employment status and use of Crohn's disease-related medical visits to measure the impact of the treatment.

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 27, 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 DiseasesInflammationIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInflammatory Bowel Diseases

Criteria

10 exclusion criteria prevent from participating
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

Show More Criteria

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 StatesOpen Atlanta Gastroenterology Associates in Google Maps
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