Epanova™ Free Fatty Acids for Symptomatic Remission Maintenance in Crohn's Disease
Data Collection
Crohn Disease+6
+ Digestive System Diseases
+ Gastroenteritis
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.364 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Atlanta Gastroenterology Associates
Atlanta, United StatesOpen Atlanta Gastroenterology Associates in Google MapsNorthwestern University Medical School
Chicago, United StatesUniversity of Chicago Medical Center
Chicago, United StatesCarle Clinic Association
Urbana, United States