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

Sponsor

Tillotts Pharma AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00074542

Collaborator

(none)

364

Enrollment

Locations

Duration (Months)

11.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

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

Study Start Date :

Sep 1, 2002

Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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