EPANOVA in Crohn's Disease, Study 1 (EPIC-1)

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. Identifier: NCT00613197
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : April 4, 2013
Information provided by:
Tillotts Pharma AG

Brief Summary:

The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Epanova Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Study Start Date : January 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: 1 Epanova Drug: Epanova
4g/day in divided doses

Placebo Comparator: 2 Placebo Drug: Epanova
4g/day in divided doses

Primary Outcome Measures :
  1. time to clinical relapse [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female subject, age 17 or older; country-specific age limitations will be followed
  2. Diagnosis of Crohn's disease confirmed by radiological studies or endoscopy or surgical pathology within 36 months prior to randomisation
  3. In remission for at least 3 months, but no longer than 12 months; remission being defined as meeting both of the two conditions: (1) clinically in remission with a CDAI of less than 150 and (2) off steroids and/or immunosuppressants for at least 3 months, if remission had been induced with such medications

Exclusion Criteria:

  1. Intolerance of omega-3 fatty acids or known allergy to fish or fish products
  2. Ongoing CD therapy with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, tube feeding, defined formula diets or parenteral nutrition
  3. In 3 months prior to randomisation received: systemic steroid therapy, azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products or preparations containing fish oil
  4. In 12 months prior to randomisation received: biologicals e.g. enbrel, infliximab, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products
  5. Chronic use of narcotics for pain control (opiates for diarrhoea are acceptable)
  6. Documented short bowel syndrome, ostomy
  7. Need for bowel surgery for CD, bowel obstruction or resection in past 3 months (a subject who had a bowel resection in the past must have had at least one relapse after the surgery)
  8. Malignancy and/or clinically significant impairment in cardiac, liver or renal function, CNS, pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD
  9. Known alcoholism or drug abuse
  10. Any medical conditions which, in the investigator's opinion, may interfere with the evaluation of the trial medication
  11. Any of the following laboratory abnormalities:

    • White blood count < 3 x 109/L
    • Lymphocyte count < 0.5 x 109/L
    • Haemoglobin < 80 g/L
    • Platelet count < 125 x 109/L or > 800 x 109/L
    • ALT or AST > 2.0 times the upper limit of normal
    • Alkaline Phosphatase > 2.0 times the upper limit of normal
    • Serum Creatinine > 1.5 times the upper limit of normal

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 identifier (NCT number): NCT00613197

University of Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Tillotts Pharma AG
Principal Investigator: Paul Rutgeerts, MD, Prof. University of Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. P. Rutgeerts, University of Leuven, Belgium Identifier: NCT00613197     History of Changes
Other Study ID Numbers: TP0307
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Tillotts Pharma AG:
Crohn's Disease

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