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

This study has been completed.
Sponsor:
Information provided by:
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT00613197
First received: January 15, 2008
Last updated: April 3, 2013
Last verified: April 2013

January 15, 2008
April 3, 2013
January 2003
August 2006   (final data collection date for primary outcome measure)
time to clinical relapse [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613197 on ClinicalTrials.gov Archive Site
CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
EPANOVA in Crohn's Disease, Study 1
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
Drug: Epanova
4g/day in divided doses
  • Experimental: 1 Epanova
    Intervention: Drug: Epanova
  • Placebo Comparator: 2 Placebo
    Intervention: Drug: Epanova
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00613197
TP0307
Yes
Prof. P. Rutgeerts, University of Leuven, Belgium
Tillotts Pharma AG
Not Provided
Principal Investigator: Paul Rutgeerts, MD, Prof. University of Leuven
Tillotts Pharma AG
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP