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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074542
First Posted: December 16, 2003
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tillotts Pharma AG
  Purpose

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.


Condition Intervention Phase
Crohn's Disease Drug: Epanova™ (Omega-3 Free Fatty Acids) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tillotts Pharma AG:

Estimated Enrollment: 364
Study Start Date: September 2002
Estimated Study Completion Date: January 2005
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074542


  Show 31 Study Locations
Sponsors and Collaborators
Tillotts Pharma AG
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00074542     History of Changes
Other Study ID Numbers: Protocol TP0308 (EPIC-2)
First Submitted: December 15, 2003
First Posted: December 16, 2003
Last Update Posted: February 21, 2007
Last Verified: October 2005

Keywords provided by Tillotts Pharma AG:
Crohn's
colon
small bowel
inflammation
steroid therapy
free fatty acids

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases