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

Tillotts Pharma

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Epanova

Study type: Interventional

Funder types: Industry

Identifiers

NCT00613197

TP0307

Details and patient eligibility

About

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

Enrollment: 384 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 2 patient groups, including a placebo group

1 Epanova

Experimental group

Treatment:

Drug: Epanova

2 Placebo

Placebo Comparator group

Treatment:

Drug: Epanova