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| Sponsored by: |
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 |
| Genetics Home Reference related topics: | Crohn disease |
| MedlinePlus related topics: | Crohn's Disease |
| ChemIDplus related topics: | Gelatin |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
Contacts and Locations
More Information
| Responsible Party: | University of Leuven, Belgium ( Prof. P. Rutgeerts ) |
| Study ID Numbers: | TP0307 |
| First Received: | January 15, 2008 |
| Last Updated: | February 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00613197 |
| 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 |
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