Clinical Trial: EPANOVA in Crohn's Disease, Study 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Rem

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

Detailed Summary:
Sponsor: Tillotts Pharma AG

Current Primary Outcome: time to clinical relapse [ Time Frame: 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: CDAI Investigator and subject global rating Quality of life C-reactive protein [ Time Frame: 52 weeks ]

Original Secondary Outcome: Same as current

Information By: Tillotts Pharma AG

Dates:
Date Received: January 15, 2008
Date Started: January 2003
Date Completion:
Last Updated: April 3, 2013
Last Verified: April 2013