Status:
COMPLETED
EPANOVA in Crohn's Disease, Study 1
Lead Sponsor:
Tillotts Pharma AG
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00613197
Start Date
January 1 2003
End Date
August 1 2006
Last Update
April 4 2013
Active Locations (1)
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1
University of Leuven
Leuven, Belgium, 3000