EPANOVA in Crohn's Disease, Study 1 - Full Text View

Sponsor:	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

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.

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
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:

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

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

No publications provided by Tillotts Pharma AG

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Leuven, Belgium ( Prof. P. Rutgeerts )
Study ID Numbers:	TP0307
Study First Received:	January 15, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00613197 History of Changes
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

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on November 05, 2009