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

Tracking Information
First Submitted Date ICMJE	January 15, 2008
First Posted Date ICMJE	February 12, 2008
Last Update Posted Date	April 4, 2013
Study Start Date ICMJE	January 2003
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 11, 2008)	time to clinical relapse [ Time Frame: 52 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00613197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 11, 2008)	CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	EPANOVA in Crohn's Disease, Study 1
Official Title ICMJE	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.
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
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Crohn's Disease
Intervention ICMJE	Drug: Epanova; 4g/day in divided doses
Study Arms	Experimental: 1 Epanova Intervention: Drug: Epanova; Placebo Comparator: 2 Placebo Intervention: Drug: Epanova
Publications *	Feagan BG, Sandborn WJ, Mittmann U, Bar-Meir S, D'Haens G, Bradette M, Cohen A, Dallaire C, Ponich TP, McDonald JW, Hébuterne X, Paré P, Klvana P, Niv Y, Ardizzone S, Alexeeva O, Rostom A, Kiudelis G, Spleiss J, Gilgen D, Vandervoort MK, Wong CJ, Zou GY, Donner A, Rutgeerts P. Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials. JAMA. 2008 Apr 9;299(14):1690-7. doi: 10.1001/jama.299.14.1690.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 11, 2008)	384
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2006
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00613197
Other Study ID Numbers ICMJE	TP0307
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Prof. P. Rutgeerts, University of Leuven, Belgium
Study Sponsor ICMJE	Tillotts Pharma AG
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Paul Rutgeerts, MD, Prof. University of Leuven
PRS Account	Tillotts Pharma AG
Verification Date	April 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP