EPANOVA in Crohn's Disease, Study 1 (EPIC-1)
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ClinicalTrials.gov Identifier: NCT00613197 |
Recruitment Status
:
Completed
First Posted
: February 12, 2008
Last Update Posted
: April 4, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | January 15, 2008 | |||
First Posted Date ICMJE | February 12, 2008 | |||
Last Update Posted Date | April 4, 2013 | |||
Study Start Date ICMJE | January 2003 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
time to clinical relapse [ Time Frame: 52 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00613197 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | EPANOVA in Crohn's Disease, Study 1 | |||
Official Title ICMJE | 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. | |||
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 |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE | Drug: Epanova
4g/day in divided doses |
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Study Arms |
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Publications * | 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. doi: 10.1001/jama.299.14.1690. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
384 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | August 2006 | |||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00613197 | |||
Other Study ID Numbers ICMJE | TP0307 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Prof. P. Rutgeerts, University of Leuven, Belgium | |||
Study Sponsor ICMJE | Tillotts Pharma AG | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Tillotts Pharma AG | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |