Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432913
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-02-07
Brief Title:
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
Sponsor:
SLA Pharma AG
Organization:
SLA Pharma AG
Study Overview
Official Title:
The Effect of Two Dose Levels of Eicosapentaenoic Acid EPA on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effect of two doses purified EPA an omega-3 fatty acid on apoptosis natural cell death and cell proliferation formation of new cells in the lining of the colon for patients with a history of colonic polyps
Detailed Description:
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps More than 90 of new large bowel cancers arise sporadically The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation formation of new cells and apoptosis natural cell death from changes in the genes involved in normal colon cells
Recent work at St Georges Hospital Medical School London has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified free-fatty acid form of eicosapentaenoic acid EPA
Comparators 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months
Recent work at St Georges Hospital Medical School London has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified free-fatty acid form of eicosapentaenoic acid EPA
Comparators 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None