NCT00613197

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

3.6 years

First QC Date

January 15, 2008

Last Update Submit

April 3, 2013

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • time to clinical relapse

    52 weeks

Secondary Outcomes (1)

  • CDAI Investigator and subject global rating Quality of life C-reactive protein

    52 weeks

Study Arms (2)

1 Epanova

EXPERIMENTAL
Drug: Epanova

2 Placebo

PLACEBO COMPARATOR
Drug: Epanova

Interventions

EpanovaDRUG

4g/day in divided doses

1 Epanova2 Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Feagan BG, Sandborn WJ, Mittmann U, Bar-Meir S, D'Haens G, Bradette M, Cohen A, Dallaire C, Ponich TP, McDonald JW, Hebuterne X, Pare 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. doi: 10.1001/jama.299.14.1690.

    PMID: 18398081DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Paul Rutgeerts, MD, Prof.

    University of Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2008

First Posted

February 12, 2008

Study Start

January 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

BE(1)