EPANOVA in Crohn's Disease, Study 1

Crohn's Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613197
• Other study ID #: TP0307
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2008
• Last updated: April 3, 2013
• Start date: January 2003
• Est. completion date: August 2006

Study information

• Verified date: April 2013
• Source: Tillotts Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthItaly: The Italian Medicines AgencyLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Epanova
4g/day in divided doses

Locations

Country	Name	City	State
Belgium	University of Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Tillotts Pharma AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to clinical relapse		52 weeks	No
Secondary	CDAI Investigator and subject global rating Quality of life C-reactive protein		52 weeks	No