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

This study has been completed.

Sponsored by: Tillotts Pharma AG
Information provided by: Tillotts Pharma AG
ClinicalTrials.gov Identifier: NCT00613197
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Drug: Epanova
Phase III

Genetics Home Reference related topics:   Crohn disease  

MedlinePlus related topics:   Crohn's Disease  

ChemIDplus related topics:   Gelatin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Tillotts Pharma AG:

Primary Outcome Measures:
  • time to clinical relapse [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:   384
Study Start Date:   January 2003
Study Completion Date:   August 2006
Primary Completion Date:   August 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Epanova: Experimental Drug: Epanova
4g/day in divided doses
2 Placebo: Placebo Comparator Drug: Epanova
4g/day in divided doses

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613197

Locations
Belgium
University of Leuven    
      Leuven, Belgium, 3000

Sponsors and Collaborators
Tillotts Pharma AG

Investigators
Principal Investigator:     Paul Rutgeerts, MD, Prof.     University of Leuven    
  More Information

Publications indexed to this study:

Responsible Party:   University of Leuven, Belgium ( Prof. P. Rutgeerts )
Study ID Numbers:   TP0307
First Received:   January 15, 2008
Last Updated:   February 11, 2008
ClinicalTrials.gov Identifier:   NCT00613197
Health Authority:   Canada: Health Canada;   Belgium: Ministry of Social Affairs, Public Health and the Environment;   Czech Republic: State Institute for Drug Control;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Israel: Ministry of Health;   Italy: The Italian Medicines Agency;   Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Tillotts Pharma AG:
Crohn's Disease  

Study placed in the following topic categories:
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:
Digestive System Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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