Back to resultsEPANOVA in Crohn's Disease, Study 1 (EPIC-1)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Epanova
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease
Eligibility Criteria
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
Sites / Locations
- University of Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1 Epanova
2 Placebo
Arm Description
Outcomes
Primary Outcome Measures
time to clinical relapse
Secondary Outcome Measures
CDAI Investigator and subject global rating Quality of life C-reactive protein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00613197
Brief Title
EPANOVA in Crohn's Disease, Study 1
Acronym
EPIC-1
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tillotts Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Epanova
Arm Type
Experimental
Arm Title
2 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Epanova
Intervention Description
4g/day in divided doses
Primary Outcome Measure Information:
Title
time to clinical relapse
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
CDAI Investigator and subject global rating Quality of life C-reactive protein
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Rutgeerts, MD, Prof.
Organizational Affiliation
University of Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
18398081
Citation
Feagan BG, Sandborn WJ, Mittmann U, Bar-Meir S, D'Haens G, Bradette M, Cohen A, Dallaire C, Ponich TP, McDonald JW, Hebuterne X, Pare 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.
Results Reference
derived
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EPANOVA in Crohn's Disease, Study 1
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