An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease
Completed
Tillotts Pharma AG
Phase 3
2002-09-01
The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission
in subjects with Crohn's Disease who are responding to steroid induction therapy.
Patient safety and quality of life will also be monitored throughout the study.
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
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Completed
Radiant Research
Phase 2
2010-09-01
The objectives of this study are to compare the relative bioavailabilities of
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of
Epanova or Lovaza during periods of high- and low -fat consumption.
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Completed
AstraZeneca
Phase 2
2010-09-01
The objectives of this study are to compare the relative bioavailabilities of
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of
Epanova or Lovaza during periods of high- and low -fat consumption.
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