An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease

February 20, 2007 updated by: Tillotts Pharma AG

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.

Study Overview

Status

Completed

Conditions

Crohn's Disease

Intervention / Treatment

Drug: Epanova™ (Omega-3 Free Fatty Acids)

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 Type

Interventional

Enrollment

364

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- - Quebec, Canada, G1S 4L8
    - Hopital St-Sacrement
- Alberta
  - Calgary, Alberta, Canada, T1Y 6J4
    - Health Sciences Centre
  - Edmonton, Alberta, Canada, T6G 2C8
    - University of Alberta
  - Edmonton, Alberta, Canada, T5H 4B9
    - Royal Alexandra Hospital
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - St. Paul's Hospital
  - Vancouver, British Columbia, Canada, V5Z 1L5
    - Vancouver General Hospital
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1R9
    - Health Sciences Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Victoria General Hospital
- Ontario
  - London, Ontario, Canada, N6A 4G5
    - London Health Sciences Centre (South Street Campus)
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre (University Campus)
  - Ottawa, Ontario, Canada, K1Y 4E9
    - The Ottawa Hospital (Civic Campus)
  - Toronto, Ontario, Canada, M5B 1W8
    - St. Michael's Hospital
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook & Women's College HSC
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
  - Montreal, Quebec, Canada, H3A 1A1
    - Royal Victoria Hospital
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H1T 2M4
    - Hopital Maisonneuve-Rosemont
  - Montreal, Quebec, Canada, H2X 3J4
    - Hôpital Saint-Luc
  - Montreal, Quebec, Canada, G1L 3L5
    - CHUQ - Pavillon St-François d'Assise
  - Québec, Quebec, Canada, G1R 2J6
    - CHUQ-Hotel-Dieu de Québec
United States
- Georgia
  - Atlanta, Georgia, United States, 30342-5006
    - Atlanta Gastroenterology Associates
- Illinois
  - Chicago, Illinois, United States, 60637
    - University Of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern University Medical School
  - Urbana, Illinois, United States, 61801
    - Carle Clinic Association
- Kentucky
  - Louisville, Kentucky, United States, 40292
    - University of Louisville, Department of Surgery
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Nebraska
  - Lincoln, Nebraska, United States, 68503
    - Gastroenterology Specialties, P.C.
- New York
  - Great Neck, New York, United States, 11021
    - Long Island Clinical Research Associates
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7032
    - University of North Carolina Chapel Hill
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tillotts Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Sponsor's Website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

December 15, 2003

First Submitted That Met QC Criteria

December 15, 2003

First Posted (Estimate)

December 16, 2003

Study Record Updates

Last Update Posted (Estimate)

February 21, 2007

Last Update Submitted That Met QC Criteria

February 20, 2007

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Protocol TP0308 (EPIC-2)

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