EPANOVA in Crohn's Disease, Study 1 (EPIC-1)
This study has been completed.
Sponsor:
Tillotts Pharma AG
Information provided by:
Tillotts Pharma AG
ClinicalTrials.gov Identifier:
NCT00613197
First received: January 15, 2008
Last updated: April 3, 2013
Last verified: April 2013
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
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 |
|---|---|
| Experimental: 1 Epanova |
Drug: Epanova
4g/day in divided doses
|
| Placebo Comparator: 2 Placebo |
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:
- 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
Contacts and Locations More Information
No publications provided by Tillotts Pharma AG
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. P. Rutgeerts, University of Leuven, Belgium |
| ClinicalTrials.gov Identifier: | NCT00613197 History of Changes |
| Other Study ID Numbers: | TP0307 |
| Study First Received: | January 15, 2008 |
| Last Updated: | April 3, 2013 |
| Health Authority: | Canada: Health Canada Belgium: Ministry of Social Affairs, Public Health and the Environment Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013