EPANOVA in Crohn's Disease, Study 1

Inclusion criteria

• Male or female subject, age 17 or older; country-specific age limitations will be followed
• Diagnosis of Crohn's disease confirmed by radiological studies or endoscopy or surgical pathology within 36 months prior to randomisation
• 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

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