EPANOVA in Crohn's Disease, Study 1

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Epanova


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Epanova<br> | Drug: Epanova<br>* 4g/day in divided doses<br>|
| Placebo Comparator: 2 Placebo<br> | Drug: Epanova<br>* 4g/day in divided doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to clinical relapse |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI Investigator and subject global rating Quality of life C-reactive protein |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease